Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GTY — Predicate Candidate Screening
44 FDA 510(k) clearances under this product code; the 50 most recent screened below.
86 daysmedian FDA review time
189 days90th percentile
44clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260342 | AllTest Strep A Rapid Test | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-30 | 87 | 0 |
| K251697 | Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus S | ACON Laboratories, Inc. | 2025-11-26 | 177 | 0 |
| K212623 | Healgen Strep A Rapid Test Strip (Throat Swab) | Healgen Scientific,, LLC | 2022-03-16 | 210 | 0 |
| K171976 | Sofia Strep A+ FIA, Sofia 2 Analyzer | Quidel Corporation | 2017-12-21 | 174 | 0 |
| K141775 | SOFIA (R) STREP A+ FIA | Quidel Corporation | 2014-12-16 | 168 | 1 |
| K133343 | WONDFO RAPID STREP A TEST | Guangzhou Wondfo Biotech Co., Ltd. | 2014-01-31 | 93 | 0 |
| K123793 | SOFIA STREP A FIA | Quidel Corporation | 2013-06-17 | 189 | 0 |
| K122718 | BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP | Becton, Dickinson and Company | 2013-02-06 | 154 | 0 |
| K091489 | CLEARVIEW ADVANCED STREP A , MODEL 737-430 | Binax, Inc. | 2009-09-04 | 107 | 0 |
| K082661 | BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A | Princeton BioMeditech Corp. | 2008-10-06 | 24 | 0 |
| K051638 | INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC | Unipath , Ltd. | 2005-12-06 | 169 | 0 |
| K040708 | STATUS FIRST STREP A | Princeton BioMeditech Corp. | 2004-11-22 | 249 | 0 |
| K031784 | ACON STREP A RAPID TEST DEVICE | ACON Laboratories, Inc. | 2003-07-14 | 34 | 2 |
| K023766 | ACON STREP A TWIST TEST DEVICE | Acon Laboratories Co. | 2003-02-10 | 90 | 1 |
| K023270 | SAS STREPALERT | Sa Scientific, Inc. | 2002-10-17 | 16 | 0 |
| K013379 | SAS STREPALERT | Sa Scientific, Inc. | 2001-12-12 | 61 | 0 |
| K011097 | QUICKVUE DIPSTICK STREP A | Quidel Corp. | 2001-05-08 | 27 | 2 |
| K010582 | ACON STREP A RAPID TEST STRIP | Acon Laboratories Co. | 2001-05-07 | 69 | 3 |
| K993456 | SAS STREP A TEST | Sa Scientific, Inc. | 2000-03-07 | 146 | 0 |
| K992658 | OSOM ULTRA STREP A TEST, MODEL 147 | Wyntek Diagnostics, Inc. | 2000-01-18 | 162 | 0 |
| K991828 | STREP B OIA | Biostar, Inc. | 1999-08-19 | 83 | 0 |
| K982373 | UNI-GOLD STREP A TEST KIT | Trinity Biotech, Plc | 1999-02-11 | 219 | 0 |
| K983386 | BIOSTREP A-DIRECT STREP A ANTIGEN TEST | Princeton BioMeditech Corp. | 1998-11-25 | 60 | 0 |
| K971349 | BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST | Princeton BioMeditech Corp. | 1997-07-07 | 88 | 0 |
| K945080 | QUICKVUE IN-LINE ONE-STEP STREP A CONTROL SWABS (POSITIVE & | Quidel Corp. | 1995-02-10 | 116 | 1 |
| K936112 | STREP B OIA | Biostar, Inc. | 1994-07-06 | 195 | 0 |
| K935667 | QTEST(R) STREP | Becton Dickinson Advanced Diagnostics | 1994-04-21 | 146 | 0 |
| K922765 | BIOSTARS STREP A OIA -- MODIFICATION | Biosearch Medical Products, Inc. | 1992-08-20 | 79 | 0 |
| K922490 | ABBOTT STREP A CONTROLS | Abbott Laboratories | 1992-07-22 | 56 | 0 |
| K905020 | SLIDEX STREPTO-KIT | Vitek Systems, Inc. | 1991-01-28 | 82 | 0 |
| K904589 | KODAK SURECELL(TM) STREP A CONTROL FLUID SET | Eastman Kodak Company | 1991-01-18 | 101 | 0 |
| K902991 | ICON STREP B IMMUNOENZYMETRIC ASSAY | Hybritech, Inc. | 1990-10-03 | 86 | 0 |
| K882811 | STREPSLIDE | Ncs Diagnostics, Inc. | 1988-10-25 | 110 | 0 |
| K864752 | ABBOTT TESTPACK(TM) STREP A POSITIVE CONTROL | Abbott Laboratories | 1987-02-26 | 83 | 0 |
| K862475 | RESPIRASTICK ENZYME IMMUNOASSAY TEST | Orion Diagnostica, Inc. | 1986-09-16 | 78 | 0 |
| K862133 | HYGEIA RAPID STREP A TEST | Hygeia Sciences | 1986-06-25 | 21 | 0 |
| K861575 | DIRECTATEX STREP A | Pacific Biotech, Inc. | 1986-06-03 | 36 | 0 |
| K840511 | STREPTOCOCCUS GR. D | Scientific Device Laboratory, Inc. | 1984-03-23 | 46 | 0 |
| K840512 | STREPTOCOCCUS PNEUMONIAE CONTROL | Scientific Device Laboratory, Inc. | 1984-03-23 | 46 | 0 |
| K840513 | STREPTOCOCCUS GR. B CONTROL | Scientific Device Laboratory, Inc. | 1984-03-23 | 46 | 0 |
| K840048 | PHADEBACT CSF POSITIVE CONTROLS | Pharmacia, Inc. | 1984-03-02 | 56 | 0 |
| K832248 | PHADEBACT STREP POSITIVE CONTROLS | Pharmacia, Inc. | 1983-09-01 | 52 | 0 |
| K831599 | MERITEC-STREP GROUP A BETA-HEMOLYTIC | Meridian Diagnostics, Inc. | 1983-08-11 | 86 | 0 |
| K812808 | BBL DIRECTIGEN TEST KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-12-30 | 85 | 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