Question 1

What types of medical devices does Alere Scarborough, Inc. primarily manufacture?

Accepted Answer

Alere Scarborough, Inc. specializes in rapid in vitro diagnostic (IVD) tests, including antigen kits for self-testing and clinical use. Their portfolio covers SARS-CoV-2 antigen tests, respiratory virus detection (such as RSV and influenza), malaria diagnostics, and rapid immunochromatographic tests (ICT) for conditions like Group A Streptococcus and Legionella. They also produce laboratory-grade devices like isothermal nucleic acid amplification analysers and photometric/spectroscopic immunoassay analysers.

Question 2

Where is Alere Scarborough, Inc. based, and how does that affect its regulatory oversight?

Accepted Answer

Alere Scarborough, Inc. is based in the United States, which means its devices fall under FDA regulation. Since the U.S. is the manufacturer’s home country, their products are evaluated and authorised through the FDA’s regulatory pathways, including submissions recorded in the FDA’s 510(k) and Unique Device Identifier (UDI) registries.

Question 3

Which regulatory registries list Alere Scarborough, Inc.’s devices, and why?

Accepted Answer

Alere Scarborough, Inc.’s devices are listed in the FDA’s 510(k) and UDI registries. The 510(k) registry tracks submissions for devices that require premarket notification to demonstrate substantial equivalence to a legally marketed predicate device, while the UDI registry ensures unique identification of medical devices for tracking and compliance purposes. These registries reflect the company’s adherence to FDA requirements for device authorisation.

Question 4

How are Alere Scarborough, Inc.’s devices classified under FDA regulations?

Accepted Answer

Alere Scarborough, Inc.’s devices are classified under various FDA categories, including Class I (low-risk, general controls), Class II (moderate-risk, requiring special controls), Class III (high-risk, requiring premarket approval), and non-classified (N) products. The classification depends on factors like the device’s intended use, risk level, and regulatory history, ensuring appropriate oversight based on potential patient risk.

Question 5

What distinguishes Alere Scarborough, Inc.’s rapid diagnostic tests from other similar products?

Accepted Answer

Alere Scarborough, Inc.’s rapid diagnostic tests are designed for quick, point-of-care or self-testing results, often using immunochromatographic technology (ICT) for ease of use in clinical or home settings. Many of their devices, like the BinaxNOW® series, are engineered for simplicity—requiring minimal training—while still delivering reliable detection for conditions like COVID-19, malaria, or RSV. Their laboratory-grade analysers, such as isothermal amplification systems, offer higher sensitivity for more complex diagnostic needs.

Device	Model / Reference	Registries	Class	Status
BinaxNOW Nasopharyngeal Swab Accessory Kit	400-065	FDA UDI	Class I	Active
BinaxNOW COVID-19 Antigen Self Test	195-260	FDA UDI	N	Active
BinaxNOW COVID-19/Flu A&B Combo Self Test	20002050	FDA UDI	Class II	Active
ID NOW™ Instrument	EQ00200X	FDA UDI	Class II	Active
Alere Reader BinaxNOW Tray Pack	LFR-004	FDA UDI	N/A	Active
Alere Determine™ HIV–1/2 Ag/Ab Combo Controls	7D2628	FDA UDI	Class II	Unknown
BinaxNOW COVID-19 Antigen Self Test	195-170	FDA UDI	Class II	Active
Alere NMP22® Urine Collection Kit	D2100E	FDA UDI	Class III	Active
Alere Reader Calibration Check Card	LFR-003	FDA UDI	N/A	Unknown
BinaxNOW™ Legionella Control Swab Pack	852-010	FDA UDI	Class II	Active
ID NOW™ Instrument	EQ00200XS	FDA UDI	Class II	Active
BinaxNOW COVID-19 Antigen Self Test	195-160	FDA UDI	Class II	Active
Alere™ i Instrument	EQ00200XS	FDA UDI	Class II	Active
BinaxNOW COVID-19 Antigen Self Test	195-269	FDA UDI	N	Active
Alere™ i Instrument	EQ00200X	FDA UDI	Class II	Active
BinaxNOW COVID-19/Flu A&B Combo Self Test	295-364	FDA UDI	Class II	Active
Alere Reader	EQ00600X	FDA UDI	N/A	Active
Osteomark NTx Urine	9006	FDA UDI	Class I	Unknown
NMP22 BladderChek Control Kit	D1250	FDA UDI	Class II	Active
Alere™ i Strep A	733-000	FDA UDI	Class II	Unknown
Binax® Legionella EIA Wash Buffer Accessory Kit	851-100	FDA UDI	Class II	Active
BinaxNOW COVID-19 Antigen Self Test	195-264	FDA UDI	N	Active
Fingerstick Sample Collection Kit	2604US199	FDA UDI	N/A	Unknown
BinaxNOW Influenza A & B Card 2 Control Swab Kit	575-080	FDA UDI	Class II	Active
Alere i RSV	435-000	FDA UDI	Class II	Unknown
BinaxNOW COVID-19/Flu A&B Combo Self Test	20002051	FDA UDI	Class II	Active
BinaxNOW COVID-19 Antigen Self Test	195-270	FDA UDI	N	Active
BinaxNOW® Malaria Positive Control Kit	665-010	FDA UDI	Class I	Active
Id Now™ Covid-19	190-000	FDA UDI	N	Unknown
BinaxNOW COVID-19 Ag Positive Control Swab Pack	195-080	FDA UDI	N	Active
BinaxNOW Streptococcus pneumoniae Antigen Card	710-000	FDA UDI	Class I	Active
ISOSTAT® Press and Rack	50C2	FDA UDI	Class II	Unknown
BinaxNOW COVID-19 Antigen Self Test	195-265	FDA UDI	N	Active
BinaxNOW RSV	430-122	FDA UDI	Class I	Active
Alere NMP22 BladderChek Control Kit	D1250	FDA UDI	Class II	Unknown
BinaxNOW Strep A Card	730-025	FDA UDI	Class I	Active
Clearview PBP2a SA Culture Colony Test	893-000	FDA UDI	Class II	Active
Alere i RSV Control Swab Kit	435-080	FDA UDI	Class II	Unknown
Alere NMP22 BladderChek Test	D1200	FDA UDI	Class III	Unknown
ID NOW Strep A 2	734-000	FDA UDI	Class II	Active
BinaxNOW COVID-19/Flu A&B Combo Self Test	295-363	FDA UDI	Class II	Active
Alere Determine™ HIV–1/2 Ag/Ab Combo	7D2648	FDA UDI	Class II	Unknown
Alere Influenza A & B Test	412-000	FDA UDI	Class II	Unknown
BinaxNOW Legionella Urinary Antigen Card	852-000	FDA UDI	Class II	Active
Alere Influenza A & B Control Swab Kit	412-080	FDA UDI	Class II	Unknown
BinaxNOW COVID-19/Flu A&B Combo Self Test	295-362	FDA UDI	Class II	Active
BinaxNOW COVID-19 Reagent Accessory Kit	195-090	FDA UDI	N	Active
BinaxNOW RSV	430-022	FDA UDI	Class I	Active
ID NOW Instrument	NAT-024R	FDA UDI	Class II	Active
Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit	575-080	FDA UDI	Class II	Unknown

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