# Alfa Scientific Designs, Inc.

- Location (FDA's records): Poway, CA
- FDA decisions: 44 (1999–2026): 44 510(k) clearances
- Product codes: DKZ (6), JHI (5), KHE (3), DJG (3), DJC (3), DIO (2), LAF (2), LCM (2), JXM (2), DOE (2), DPK (2), DJR (2)
- Predicates its devices cite: 37 (15 its own); citations of its devices by later devices: 23 (15 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Drial Consultants, Inc.: 8 (https://510kreport.com/company/drial-consultants)
- Syntron Bioresearch, Inc.: 4 (https://510kreport.com/company/syntron-bioresearch)
- Wyntek Diagnostics, Inc.: 3 (https://510kreport.com/company/wyntek-diagnostics)
- Smithkline Diagnostics, Inc.: 2 (https://510kreport.com/company/smithkline-diagnostics)
- Tianjin New Bay Bioresearch Co., Ltd.: 1 (https://510kreport.com/company/tianjin-new-bay-bioresearch)
- Unipath, Ltd.: 1 (https://510kreport.com/company/unipath)
- Vancouver Biotech, Ltd.: 1 (https://510kreport.com/company/vancouver-biotech)
- ACON Laboratories, Inc.: 1 (https://510kreport.com/company/acon-laboratories)

## Firms that cite its devices most
- Shanghai Venture Bio-Tech Co., Ltd.: 2 (https://510kreport.com/company/shanghai-venture-bio-tech)
- Tianjin New Bay Bioresearch Co., Ltd.: 1 (https://510kreport.com/company/tianjin-new-bay-bioresearch)
- Hangzhou AllTest Biotech Co., Ltd.: 1 (https://510kreport.com/company/hangzhou-alltest-biotech)
- Yd Diagnostics: 1 (https://510kreport.com/company/yd-diagnostics)
- Otsuka Pharmaceutical Co., Ltd.: 1 (https://510kreport.com/company/otsuka-pharmaceutical)
- Orient Gene Biotech: 1 (https://510kreport.com/company/orient-gene-biotech)
- SEKISUI Diagnostics, LLC: 1 (https://510kreport.com/company/sekisui-diagnostics)

## Its most-cited devices
- K063545: Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine Test (Cassette, Dip-Strip), Cocaine, Methamphetamine (2007), cited by 3
- K021423: Instant-View Fecal Occult Blood Rapid Test (2002), cited by 3
- K173303: INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use) (2018), cited by 3
- K060527: Instant-View Bup/Nbup Urine Test.  Instant-Verdict Bup/Nbup Urine Test;  Instant-Confirmatory Bup/Nbup Urine Test (2006), cited by 2
- K022915: Instant-View Propoxyphene (PPX) Urine Test (2002), cited by 2
- K070660: Instant-View Fecal Occult Blood (Fob) Rapid Test (2007), cited by 2

## Recent decisions
- K262299: Instant-View® hCG Combo II Cassette Test (Sep 22, 2026)
- K173303: INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use) (Feb 23, 2018)
- K173212: Instant-view-PLUS immunochemical Fecal Occult Blood Test (Feb 15, 2018)
- K152122: Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use) (Jun 24, 2016)
- K131645: Instant-View Multi-Drug of Abuse Urine Test (Cup, Panel Cassette) (Oct 7, 2013)
- K100051: Instant-View Milti-Drug of Abuse Urine Test (Panel, Cup), Instant-Verdict Multi-Drug of Abuse Urine Test (Panel, Cup) (Jul 6, 2010)
- K070660: Instant-View Fecal Occult Blood (Fob) Rapid Test (Jun 21, 2007)
- K063545: Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine Test (Cassette, Dip-Strip), Cocaine, Methamphetamine (May 7, 2007)

Source page: https://510kreport.com/company/alfa-scientific-designs