Grouping medical devices as an IVD Cluster

IVD reagents or articles with the same product owner that only fall under risk class B. They are of a common test methodology and fall under the same IVD cluster category.

IVD Cluster grouping requirements

An IVD Cluster comprises a number of in vitro diagnostic reagents or articles that are:

From the same product owner.
Of the same risk classification (Class B only).
Of a common test methodology.
Of the same IVD Cluster category.

The IVD Cluster may include analysers that are designed for use with the reagents in the IVD Cluster.

The listing of the IVD test kits, reagents and their accessories on the SMDR upon approval may differ from the initial grouping.

Types of IVD Clusters

IVD Clusters	How to list
Individual (Single) reagents or articles. Test kits. Family of reagents or articles within an IVD Cluster.	List separately on the Singapore Medical Device Register (SMDR). Note: The different device brand names, and common intended purpose would be key considerations for the separate listings.
IVD Clusters which include IVD analyser. IVD Test Kit which include IVD analyser.	Select one of the following options: List together as an IVD system. List the IVD analyser separately from the IVD test kit as a split listing.

IVD Clusters

How to list

Individual (Single) reagents or articles.
Test kits.
Family of reagents or articles within an IVD Cluster.

List separately on the Singapore Medical Device Register (SMDR).

Note: The different device brand names, and common intended purpose would be key considerations for the separate listings.

IVD Clusters which include IVD analyser.
IVD Test Kit which include IVD analyser.

Select one of the following options:

List together as an IVD system.
List the IVD analyser separately from the IVD test kit as a split listing.

Grouping limitations

The IVD Cluster grouping is only used for product registration, and will not apply as a grouping criterion for the addition of models through a Change Notification.

All devices and articles that are listed as part of a Cluster can be supplied separately but solely for the registered intended purpose.

A reagent or article that is intended for multiple usage categories, such that it can be grouped in more than one IVD Cluster, can be grouped as part of any IVD Cluster.

List of IVD Cluster Categories

This list of IVD Cluster categories only applies to Class B IVD devices. The label of each reagent or article should state clearly whether it is intended to be used alone or in combination, for the same category.

Methodology	Cluster Category (Closed list)	Examples of analytes
Clinical chemistry	Enzymes	Acid Phosphatase Alpha-Amylase Creatine Kinase Gamma-Glutamyl Transferase Lactate Dehydrogenase Lipase
Clinical chemistry	Substrates	Albumin Bilirubin Urea/blood urea nitrogen Cholesterol Creatinine Glucose
Clinical chemistry	Electrolytes Reagents	Ammonia Bicarbonate Calcium Chloride Magnesium Phosphate inorganic/phosphorus
Clinical chemistry	Electrolyte Electrodes	Ammonia electrodes Carbon dioxide (bicarbonate) electrodes Calcium electrodes Chloride electrodes Magnesium electrodes Potassium electrodes
Clinical chemistry	Substrate electrodes/biosensors	Creatinine Electrodes Glucose Electrodes Glycated Hemoglobin Electrodes Lactate Electrodes Urea Electrodes Bilirubin Electrodes
Immunochemistry	Immunoglobulins (without IgE)	Immunoglobulin A Immunoglobulin D Immunoglobulin G Immunoglobulin M Immunofixation kits
Immunochemistry	Complement components	Complement component C1q Complement component C1 inactivator Complement component C3/C3c Complement component Bb Complement component C4 Complement component C5a
Immunochemistry	Transport proteins	Albumin Ceruloplasmin Haptoglobin Hemopixin Lactoferrin Pre-albumin/Transthyretin
Immunochemistry	Lipoproteins	Apolipoprotein A I Apolipoprotein A II Apolipoprotein B Apolipoprotein E Sub-typing Lipoprotein (a)
Immunochemistry	Other Specific Proteins	a1-Acid Glycoprotein a1-Antitrypsin a1- Microglobulin Fribonectin Immuno Reactive Trypsin
Immunochemistry	Allergy	Immunoglobuin E - Total Immunoglobulin E - Screen Immunoglobulin E - Specific, monotest/monoresult Allergen specific IgA Allergen specific IgG
Immunochemistry	Cancer markers	G1- marker CA242 p53
Immunochemistry	Thyroid function markers	Free triiodothyronine Free thyroxine Thyroid stimulating hormone T-uptake Thyroglobulin Neonatal thyroxine
Immunochemistry	Fertility/Pregnancy Hormones/ Proteins	Androstenedione Estradiol Prolactin Human Placental Lactogen Estriol
Immunochemistry	Diabetes assays (hormones)	C-peptide Glucagon Insulin Glycosylated/glycated haemoglobin Islet Cell Ab Proinsulin
Immunochemistry	Renal metabolism assays	Aldosterone Angiotensin I/II Angiotensin converting enzyme Cortisol Renine
Immunochemistry	Bone and mineral metabolism assays	Bone alkaline phosphatase Calcitonin Cross-linked C-Telopeptides Cross-linked N-Telopeptides Cyclic adenosin monophosphate Hydroxyproline
Immunochemistry	Endocrine hormones and peptides	Adrenocorticotropic Hormone Human Growth Hormone Insulin-like Growth Factor I Insulin-like Growth Factor Binding Protein 1 Vasointestinal Peptide Vasopressin
Immunochemistry	Neuroendocrine Function Assays	Bombesin 17-Hydroxy-Ketosterone β-Endorphin Neurotensin Somatostatin Substance P
Immunochemistry	Other individual and specified hormones	Gastrin Gonadotropin-releasing hormone Melatonin Pepsinogen Adrenalin Dopamine
Immunochemistry	Anaemia	Erythropoietin Ferritin Folate Iron Iron binding capacity Soluble transferrin receptor
Immunochemistry	Vitamins	Vitamin B1 Vitamin B2 Vitamin B6 Vitamin B12 Vitamin D (cholecalciferol) Intrinsic factor (blocking antibody)
Immunochemistry	Drug monitoring	Caffeine Benzodiazepines Penicillins Tetracyclines
Immunochemistry	Toxicology	Amphetamines Cocaine Morphine Phencyclidine Acetaminophen Catecholamines Ethanol Salicylate
Immunochemistry	Auto-immune diseases	Anti-nuclear antibodies (ANAs) Anti-topoisomerase Organ-specific autoantibodies Circulating Immuno-complex TSH Receptor antibodies Anti-Cardiolipin antibodies
Immunochemistry	Rheumatoid- Inflammatory diseases markers	Anti-Streptococcal Hyaluronidase Anti-Streptokinase Anti-Streptolysin O C-Reactive Protein Anti-Staphylolysin Anti-Streptococcal Screening
Immunochemistry	Liver function	MEGX Carbohydrate Deficient Transferrin
Immunochemistry	Cardiac markers	Homocysteine ST2 Galectin-3 Myeloperoxidase (MPO)
Immunochemistry	Bacterial Infection - Immunology	Bacillus subtilis Pseudomonas Aeruginosa Helicobacter Pylori Lactobacillus casei
Immunochemistry	Viral infection - Immunology	Norovirus Rotavirus Hantavirus
Immunochemistry	Parasitic Infection - Immunology	Leishmania
Immunochemistry	Fungal Infection - Immunology	Candida albicans Aspergillus
Haematology/histology/cytology (blood tests for transfusions excluded)	Haemoglobin testing	Hemoglobin determinations (Total Hb) Fractional oxyhemoglobin (FO2Hb) Fractional carboxyhemoglobin (FCOHb) Fractional methemoglobin (FMetHb) Fractional deoxyhemoglobin (FHHb)
Haematology/histology/cytology (blood tests for transfusions excluded)	General coagulation tests	Prothrombin Time Thrombin Time Activated Clotting Time Activated Partial Thromboplastin Time
Haematology/histology/cytology (blood tests for transfusions excluded)	Haemostasis (coagulation)	Fibrinogen Protein C and Protein S reagents C1-inhibitors Alpha-Antiplasmin Fibrin Factor XIII Platelet Factor 4 Plasminogen
Haematology/histology/cytology (blood tests for transfusions excluded)	Other hematology tests	Complete blood count Hematocrit Erythrocyte sedimentation rate
Haematology/histology/cytology (blood tests for transfusions excluded)	Cytokines (lymphokines)/ immunomodulators	Interferons Soluble antigens/receptors Tumor necrosis factors Colony stimulating factors Tumor necrosis factors receptors
Haematology/histology/cytology (blood tests for transfusions excluded)	Histology/cytology reagents	Cytochemical staining Embedding, fixing, mounting media Stain solutions Immunohistology kits
Microbiology culture	Culture media	Dehydrated culture media (DCM) Additives for DCM Prepared media (tubes, bottles, plates) Cells, media, serum for viral culture
Microbiology culture	Susceptibility testing (Testing the susceptibility of bacteria to certain antibiotics)	Erythromycin susceptibility test for Staphylococcus aureus Tobramycin susceptibility test for Pseudomonas aeruginosa Fungal susceptibility testing
Microbiology culture	Biochemical culture Identification (ID)	Gram negative manual ID Gram positive manual ID Other ID kits manual - anaerobes, fastidious
Microbiology culture	Immunological culture Identification (ID)	Streptococci grouping slide tests Serotyping (Shigella etc.)
Microbiology culture	Nucleic Acid (NA) based culture identification (ID)	Streptococci Shigella
Microbiology culture	Serological identification (ID)	For Parasitology and Mycology (Fungi and Yeast)
Microbiology culture	Bacterial Infections (detection by NA reagents)	Streptococci Shigella
Microbiology culture	Viral infections (detection by NA reagents)	Para-influenza NA reagents
Microbiology culture	Fungal infections	Fungi NA reagents Candida albicans Aspergillus

Last updated: 31 Dec 2018