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 COVID-19/Flu A&B Combo Self Test	295-361	FDA UDI	Class II	Active
DIGIVAL Calibration Check Card Pack	LFR-003	FDA UDI	N/A	Active
Alere™ PBP2a SA Culture Colony Test	893-000	FDA UDI	Class II	Unknown
NMP22 BladderChek Test	D1200	FDA UDI	Class III	Active
ISOSTAT® Consumables	50C9	FDA UDI	Class II	Active
Alere i Strep A 2 Control Swab Kit	734-080	FDA UDI	Class II	Unknown
ISOLATOR™ 1.5 mL Microbial Tubes	50C5	FDA UDI	Class I	Unknown
BinaxNOW COVID-19/Flu A&B Combo Self Test	20002056	FDA UDI	Class II	Active
BinaxNOW COVID-19 Antigen Self Test	195-262	FDA UDI	N	Active
BinaxNOW RSV Control Swab Kit	430-080	FDA UDI	Class I	Active
BinaxNOW COVID-19 Antigen Self Test	195-263	FDA UDI	N	Active
BinaxNOW COVID-19 Antigen Self Test	195-266	FDA UDI	N	Active
ID NOW Influenza A & B 2	427-000	FDA UDI	Class II	Active
BinaxNOW COVID-19 Antigen Self Test	195-268	FDA UDI	N	Active
ID NOW™ COVID-19 Control Swab Kit	190-080	FDA UDI	N	Unknown
Determine™ HIV–1/2 Ag/Ab Combo	7D2648	FDA UDI	Class II	Active
BinaxNOW® Malaria	665-025	FDA UDI	Class II	Active
Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit	K173653	FDA 510(k)	Class II	Active
Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit	K162642	FDA 510(k)	Class II	Active
Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit	K151464	FDA 510(k)	Class II	Active
BinaxNOW G6PD Test	K161364	FDA 510(k)	Class II	Active
Actim Prom	K123986	FDA 510(k)	Class I	Active
Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit	K161375	FDA 510(k)	Class II	Active
Alere I Strep A	K141757	FDA 510(k)	Class II	Active
Alere i Instrument, Alere i Influenza A & B, Alere i Strep A	K151690	FDA 510(k)	Class II	Active
Alere Pbp2a Test	K121905	FDA 510(k)	Class II	Active
Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2	K173932	FDA 510(k)	Class II	Active
ID NOW Influenza A & B 2	K190204	FDA 510(k)	Class II	Active
Alere BinaxNOW Influenza A & B Card 2, Alere Reader	K181853	FDA 510(k)	Class II	Active
Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit	K173502	FDA 510(k)	Class II	Active
WOUNDCHEK Bacterial Status	DEN180014	FDA 510(k)	Class II	Active
Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit	K171792	FDA 510(k)	Class II	Active
Alere Pbp2a Sa/Cons Culture Colony Test	K133851	FDA 510(k)	Class II	Active
Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument	K163266	FDA 510(k)	Class II	Active

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