Question 1

What types of medical devices does Alfa Scientific Designs, Inc. manufacture?

Accepted Answer

Alfa Scientific Designs, Inc. specializes in rapid immunochemical test kits designed for clinical and point-of-care use. Their portfolio includes urine cassettes and cup tests for detecting drugs of abuse (such as methamphetamine, cocaine, cannabinoids, and opiates), faecal occult blood, and human chorionic gonadotropin (hCG) for pregnancy testing. These tests are formulated to provide immediate visual results, often used in settings like emergency rooms, clinics, or law enforcement for quick screening.

Question 2

Where is Alfa Scientific Designs, Inc. based, and where are its devices authorized?

Accepted Answer

Alfa Scientific Designs, Inc. is based in the United States. Their devices are authorized for use in the U.S., where they are listed in regulatory databases such as the FDA’s 510(k) and Unique Device Identifier (UDI) systems. These registries track submissions for devices that have undergone the necessary regulatory pathways to demonstrate safety and performance.

Question 3

How are the devices manufactured by Alfa Scientific Designs, Inc. classified under FDA regulations?

Accepted Answer

The devices produced by Alfa Scientific Designs, Inc. fall into three classification categories under FDA regulations: Class I (generally low-risk devices with minimal regulatory controls), Class II (devices requiring special controls to ensure safety and effectiveness), and unclassified (U) devices, which may require additional evaluation or have unique risk profiles. Classification depends on factors like the device’s intended use, potential risks, and the nature of the test results.

Question 4

Which regulatory registries list the devices made by Alfa Scientific Designs, Inc.?

Accepted Answer

The devices manufactured by Alfa Scientific Designs, Inc. are listed in the FDA’s 510(k) Premarket Notification database and the Unique Device Identifier (UDI) system. The 510(k) registry tracks submissions for devices that claim substantial equivalence to a legally marketed predicate device, while the UDI system ensures standardized identification of medical devices for tracking, traceability, and regulatory compliance purposes.

Question 5

What kinds of tests does Alfa Scientific Designs, Inc. offer for fertility and health screening?

Accepted Answer

Alfa Scientific Designs, Inc. offers rapid immunochemical tests for fertility screening, specifically human chorionic gonadotropin (hCG) detection, which is commonly used in pregnancy testing. They also provide faecal occult blood tests, which are designed for early detection of potential gastrointestinal issues. These tests are formulated for point-of-care use, delivering quick results to aid in clinical decision-making.

Device	Model / Reference	Registries	Class	Status
INSTANT-VIEW Cocaine (150) Urine Dip-Strip Test	03-3058	FDA UDI	Class II	Active
INSTANT-VIEW Methamphetamine (500) Urine Cassette Test	03-3033	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP300, COC150, MET300, MOR, PCP, T	03-3692	FDA UDI	Class II	Active
INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)	03-4702	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test COC, MET1000, MOR2000, PCP, THC	03-3578	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR300	03-3917	FDA UDI	Class II	Active
INSTANT-VIEW Multi Drugs of Abuse Dip Test COC150, THC	03-6260	FDA UDI	Class II	Active
INSTANT-VIEW TCA Urine Cassette Test	03-2972	FDA UDI	Class II	Active
INSTANT-VIEW FSH Midstream Cassette Test	02-2560	FDA UDI	Class I	Active
INSTANT-VIEW Benzodiazepine (BZD) Urine Dip-Strip Test	03-3137	FDA UDI	Class II	Active
INSTANT-VIEW Barbiturate Urine Dip Cassette Test	03-3152QW	FDA UDI	Class II	Active
INSTANT-VIEW Marijuana (THC) Urine Dip Cassette Test	03-3072QW	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, COC, MOR2000, THC	03-3458	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, THC, XTC	03-3661	FDA UDI	Class II	Active
Insant-View Pregnancy Urine Cassette Test	02-2482	FDA UDI	Class II	Active
INSTANT-VIEW Morphine/Opiates (2000) Urine Dip-Strip Test	03-3097	FDA UDI	Class II	Active
INSTANT-VIEW H. Pylori Whole Blood/Serum Cassette Test	05-9494	FDA UDI	Class I	Active
INSTANT-VIEW Troponin I Whole Blood/Serum Test (Cassette)	05-8575	FDA UDI	Class II	Active
INSTANT-VIEW Multi-Drugs of Abuse Dip Test BUP, BZD, COC, MOR300, MTD, THC	03-6633	FDA UDI	Class II	Active
INSTANT-VIEW Amphetamine Urine Dip Cassette Test	03-3012QW	FDA UDI	Class II	Active
INSTANT-VIEW Methamphetamine (1000) Urine Cassette Test	03-3032	FDA UDI	Class II	Active
INSTANT-VIEW Pregnancy Urine Cassette Test	02-2486	FDA UDI	Class II	Active
INSTANT-VIEW MOR300 Urine Dip Cassette Test	03-3093QW	FDA UDI	Class II	Active
INSTANT-VIEW TCA Urine Dip Cassette Test	03-2972QW	FDA UDI	Class II	Active
INSTANT-VIEW Marijuana (THC) Urine Cassette Test	03-3072	FDA UDI	Class II	Active
Instant-view-PLUS immunochemical Fecal Occult Blood Test	K173212	FDA 510(k)	Class II	Active
Instant-View Amphetamine Urine Cassette Test	K994395	FDA 510(k)	Class II	Active
Multi-Drug Of Abuse Urine Test, Urine Cup Test, Amphetamine Urine Test(cassette, Dip-Strip), Cocaine, Methamphetamine	K063545	FDA 510(k)	Class II	Active
Instant-View Morphine (2000) Urine Cassette Test	K010080	FDA 510(k)	Class II	Active
Instant-View Troponin I Test	K042227	FDA 510(k)	Class II	Active
Instant-View Pregnancy Urine Mid-Stream Test	K984075	FDA 510(k)	Class II	Active
Instant-View Multi-Drug Screen Urine Test	K022564	FDA 510(k)	Class II	Active
Instant-View Cocaine (benzylecgonine) Urine Cassette Test	K994398	FDA 510(k)	Class II	Active
Modification To Instant-View Methamphetamine (meth 1000) Urine Test (dip Strip)	K003845	FDA 510(k)	Class II	Active
Instant-View Phencyclidine (pcp) Urine Dip Strip Test	K010045	FDA 510(k)	U	Active
Instant-View Morphine Urine Cassette Test	K994404	FDA 510(k)	Class II	Active
Instant-View Barbituate Urine Dip Strip Test	K010125	FDA 510(k)	Class II	Active
Instant-View Fecal Occult Blood Rapid Test	K021423	FDA 510(k)	Class II	Active
Modification To Instant-View Methamphetyamine (meth1000) Urine Test (cassette)	K003847	FDA 510(k)	Class II	Active
Instant-View Multi-Drug Of Abuse Urine Test (cup, Panel Cassette)	K131645	FDA 510(k)	Class II	Active
Instant-View Mdma (ecstasy, Xtc) Urine Test	K022501	FDA 510(k)	Class II	Active
Instant-View Cocaine (benzylecgonine) Urine Dip Strip Test	K994403	FDA 510(k)	Class II	Active
Instant-View Marijuana Urine Cassette Test	K994405	FDA 510(k)	Class II	Active
Instant-View Benzodiazepine (bzd) Urine Test (dip Strip)	K003879	FDA 510(k)	Class II	Active
Instant-View Fecal Occult Blood (fob) Rapid Test	K070660	FDA 510(k)	Class II	Active
Instant-View Bup/Nbup Urine Test. Instant-Verdict Bup/Nbup Urine Test; Instant-Confirmatory Bup/Nbup Urine Test	K060527	FDA 510(k)	Class II	Active
Instant-View Tca Urine Test	K022693	FDA 510(k)	Class II	Active
Instant-View H. Pylori One Step Rapid Test	K024360	FDA 510(k)	Class I	Active
Instant-View Methamphetamine Urine Cassette Test	K994400	FDA 510(k)	Class II	Active
Instant-View Pregnancy Combo Test	K984077	FDA 510(k)	Class II	Active

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