Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alfa Scientific Designs, Inc. — Predicate Candidate Screening
43 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
147 daysmedian FDA review time
220 days90th percentile
43clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K173303 | INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cu | Alfa Scientific Designs, Inc. | 2018-02-23 | 128 | 0 |
| K173212 | Instant-view-PLUS immunochemical Fecal Occult Blood Test | Alfa Scientific Designs, Inc. | 2018-02-15 | 136 | 0 |
| K152122 | Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-V | Alfa Scientific Designs, Inc. | 2016-06-24 | 330 | 0 |
| K131645 | INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASS | Alfa Scientific Designs, Inc. | 2013-10-07 | 124 | 0 |
| K100051 | INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), IN | Alfa Scientific Designs, Inc. | 2010-07-06 | 179 | 0 |
| K070660 | INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST | Alfa Scientific Designs, Inc. | 2007-06-21 | 104 | 0 |
| K063545 | MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE U | Alfa Scientific Designs, Inc. | 2007-05-07 | 164 | 0 |
| K060527 | INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP U | Alfa Scientific Designs, Inc. | 2006-07-25 | 147 | 0 |
| K042227 | INSTANT-VIEW TROPONIN I TEST | Alfa Scientific Designs, Inc. | 2004-11-19 | 94 | 0 |
| K024360 | INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST | Alfa Scientific Designs, Inc. | 2003-06-10 | 162 | 0 |
| K022693 | INSTANT-VIEW TCA URINE TEST | Alfa Scientific Designs, Inc. | 2002-12-09 | 118 | 0 |
| K022915 | INSTANT-VIEW PROPOXYPHENE (PPX) URINE TEST | Alfa Scientific Designs, Inc. | 2002-11-29 | 87 | 0 |
| K022501 | INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST | Alfa Scientific Designs, Inc. | 2002-11-13 | 107 | 0 |
| K022829 | INSTANT-VIEW LH OVULATION PREDICTING TEST | Alfa Scientific Designs, Inc. | 2002-11-05 | 71 | 0 |
| K022564 | INSTANT-VIEW MULTI-DRUG SCREEN URINE TEST | Alfa Scientific Designs, Inc. | 2002-08-30 | 28 | 0 |
| K021423 | INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST | Alfa Scientific Designs, Inc. | 2002-06-17 | 45 | 0 |
| K010014 | INSTANT-VIEW METHADONE URINE DIP STRIP TEST | Alfa Scientific Designs, Inc. | 2001-05-29 | 147 | 0 |
| K003881 | INSTANT-VIEW BENZODIAZEPINE (BZD) URINE CASSETTE TEST | Alfa Scientific Designs, Inc. | 2001-05-29 | 165 | 0 |
| K010079 | INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST | Alfa Scientific Designs, Inc. | 2001-05-29 | 139 | 0 |
| K010045 | INSTANT-VIEW PHENCYCLIDINE (PCP) URINE DIP STRIP TEST | Alfa Scientific Designs, Inc. | 2001-05-29 | 144 | 0 |
| K003847 | MODIFICATION TO INSTANT-VIEW METHAMPHETYAMINE (METH1000) URI | Alfa Scientific Designs, Inc. | 2001-05-29 | 168 | 0 |
| K010125 | INSTANT-VIEW BARBITUATE URINE DIP STRIP TEST | Alfa Scientific Designs, Inc. | 2001-05-29 | 183 | 0 |
| K010047 | INSTANT-VIEW PHENCYCLIDINE (PCP) URINE CASSETTE TEST | Alfa Scientific Designs, Inc. | 2001-05-29 | 144 | 0 |
| K010080 | INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TEST | Alfa Scientific Designs, Inc. | 2001-05-29 | 139 | 0 |
| K003845 | MODIFICATION TO INSTANT-VIEW METHAMPHETAMINE (METH 1000) URI | Alfa Scientific Designs, Inc. | 2001-05-29 | 168 | 0 |
| K003647 | INSTANT-VIEW BARBITURATE URINE CASSETTE TEST | Alfa Scientific Designs, Inc. | 2001-05-29 | 183 | 0 |
| K010015 | INSTANT-VIEW METHADONE URINE CASSETTE TEST | Alfa Scientific Designs, Inc. | 2001-05-29 | 147 | 0 |
| K003879 | INSTANT-VIEW BENZODIAZEPINE (BZD) URINE TEST (DIP STRIP) | Alfa Scientific Designs, Inc. | 2001-05-29 | 165 | 0 |
| K994403 | INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE DIP STRIP TEST | Alfa Scientific Designs, Inc. | 2000-08-14 | 230 | 0 |
| K994406 | INSTANT-VIEW METHAMPHETAMINE URINE DIP STRIP TEST | Alfa Scientific Designs, Inc. | 2000-08-14 | 230 | 0 |
| K994395 | INSTANT-VIEW AMPHETAMINE URINE CASSETTE TEST | Alfa Scientific Designs, Inc. | 2000-08-07 | 223 | 0 |
| K994399 | INSTANT-VIEW AMPHETAMINE URINE DIP STRIP TEST | Alfa Scientific Designs, Inc. | 2000-08-04 | 220 | 0 |
| K994400 | INSTANT-VIEW METHAMPHETAMINE URINE CASSETTE TEST | Alfa Scientific Designs, Inc. | 2000-08-04 | 220 | 0 |
| K994398 | INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE CASSETTE TEST | Alfa Scientific Designs, Inc. | 2000-07-27 | 212 | 0 |
| K994409 | INSTANT-VIEW OPIATES/MORPHINE URINE DIP STRIP TEST | Alfa Scientific Designs, Inc. | 2000-07-10 | 195 | 0 |
| K994404 | INSTANT-VIEW MORPHINE URINE CASSETTE TEST | Alfa Scientific Designs, Inc. | 2000-07-05 | 190 | 0 |
| K994410 | INSTANT-VIEW MARIJUANA (THC) URINE DIP STRIP TEST | Alfa Scientific Designs, Inc. | 2000-06-21 | 176 | 0 |
| K994405 | INSTANT-VIEW MARIJUANA URINE CASSETTE TEST | Alfa Scientific Designs, Inc. | 2000-06-02 | 157 | 0 |
| K984079 | INSTANT-VIEW PREGNANCY URINE DIP-STRIP TEST | Alfa Scientific Designs, Inc. | 1999-02-16 | 92 | 0 |
| K984080 | INSTANT-VIEW PREGNANCY COMBO DIP-STRIP TEST | Alfa Scientific Designs, Inc. | 1999-02-16 | 92 | 0 |
| K984077 | INSTANT-VIEW PREGNANCY COMBO TEST | Alfa Scientific Designs, Inc. | 1999-02-16 | 92 | 0 |
| K984076 | INSTANT-VIEW PREGNANCY URINE TEST | Alfa Scientific Designs, Inc. | 1999-02-16 | 92 | 0 |
| K984075 | INSTANT-VIEW PREGNANCY URINE MID-STREAM TEST | Alfa Scientific Designs, Inc. | 1999-02-16 | 92 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda