Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JXA — Predicate Candidate Screening
44 FDA 510(k) clearances under this product code; the 50 most recent screened below.
61 daysmedian FDA review time
208 days90th percentile
44clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K011043 | OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR | Osmetech | 2001-11-30 | 239 | 0 |
| K981084 | URISCREEN | Diatech Diagnostics,Inc. | 1998-10-07 | 196 | 0 |
| K972676 | URINE SCREENING DEVICE | Combact Diagnostic Systems , Ltd. | 1998-02-23 | 222 | 0 |
| K952246 | TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT | Tri-Tech, Inc. | 1995-06-20 | 39 | 0 |
| K950257 | MULTIPLE (IZON DBS & URINE COLLECTION KIT) | Izon Business Products, Inc. | 1995-04-14 | 81 | 0 |
| K950221 | MULTIPLE (IZON BLOOD & URINE COLLECTION KIT) | Izon Business Products, Inc. | 1995-03-21 | 61 | 0 |
| K950246 | MULTIPLE (IZON URINE COLLECTION KIT) | Izon Business Products, Inc. | 1995-03-21 | 60 | 0 |
| K934759 | CULTURIA MACCONKEY-MUG | Clinical Convenience Products, Inc. | 1994-09-09 | 340 | 0 |
| K924218 | BAC-T-SCREEN | Biomerieux Vitek, Inc. | 1993-02-03 | 167 | 0 |
| K921045 | DIASLIDE URINE CULTURING DEVICE | Savyon Diagnostics , Ltd. | 1992-09-28 | 208 | 0 |
| K911846 | URI-THREE(TM), MODIFICATION | Culture Kits, Inc. | 1991-10-04 | 169 | 0 |
| K903470 | QUALTURE | Future Medical Technologies Intl., Inc. | 1990-12-13 | 134 | 0 |
| K894805 | RAPIDEC UR | Dms Products, Inc. | 1989-09-26 | 60 | 0 |
| K892216 | GEN-PROBE PACE SYSTEM URINE SCREEN | Gen-Probe, Inc. | 1989-09-15 | 165 | 0 |
| K882211 | URISCREEN | Diatech Diagnostica , Ltd. | 1988-09-30 | 127 | 0 |
| K883385 | RESUBMITTED UTISCREEN(TM) BACTERIAL ATP TEST | Los Alamos Diagnostics | 1988-09-07 | 29 | 0 |
| K881439 | MODIFIED UTISCREEN(TM) BACTERIAL ATP TEST SYSTEM | Los Alamos Diagnostics | 1988-04-28 | 23 | 0 |
| K873086 | ROUND 1 | Bioclinical Systems, Inc. | 1987-08-24 | 18 | 0 |
| K870731 | LYFO KWIK(TM) RUS KIT | Micro-Bio-Logics | 1987-06-17 | 112 | 0 |
| K864177 | N-D URINE TUBE SYSTEM (N-D TUBE/CAP/PIPETTE) | Cls Co. | 1987-02-24 | 123 | 0 |
| K864202 | UTISCREEN(R) BACTERIAL ATP TEST | Los Alamos Diagnostics | 1987-02-13 | 109 | 0 |
| K862195 | RAPID BACTERIURIA SCREEN (RBS) | New Horizons Diagnostics Co. | 1986-06-30 | 21 | 0 |
| K861631 | SLIDE CULTURE U 'EIKEN' | Syn-Kit, Inc. | 1986-06-10 | 42 | 0 |
| K860905 | URICHECK | Difco Laboratories, Inc. | 1986-04-04 | 25 | 0 |
| K860483 | FILTRA-CHECK-UTI | Applied Polytechnology, Inc. | 1986-04-04 | 53 | 0 |
| K851399 | BAC-T-SCREEN | Marion Laboratories, Inc. | 1985-06-04 | 56 | 0 |
| K843833 | BACTERIURIA DETECT DEVICE, MULTI SAMPLER | Applied Polytechnology, Inc. | 1984-11-29 | 59 | 0 |
| K843834 | BACTERIURIA DETECT. DEVICE APTEK II | Applied Polytechnology, Inc. | 1984-11-29 | 59 | 0 |
| K833834 | ORTHO BACTERIURIA DETECTION SYS | Ortho Diagnostic Systems, Inc. | 1984-03-12 | 130 | 0 |
| K832975 | BACTERUERIA SCREENING PROCEDURE | Turner Designs, Inc. | 1983-11-14 | 74 | 0 |
| K830252 | DIPCHEX DIP-SLIDE CULTURE SYS | Granite Diagnostics, Inc. | 1983-03-07 | 41 | 0 |
| K823850 | BAC-T-SCREEN BACTERIURIA DETECTION DEV | Marion Laboratories, Inc. | 1983-03-01 | 70 | 0 |
| K820126 | RAPID BACTERIURIA SCREENING TEST | Analytical Luminescence Laboratory, Inc. | 1983-01-07 | 354 | 0 |
| K810746 | LUMAC'S BACTERIURIA SCREENING KIT | Lumac | 1981-07-31 | 134 | 0 |
| K800626 | URI-DIP (R) | Pharma-Medica of Scandinavia, Ltd. | 1980-04-24 | 36 | 0 |
| K800215 | CULTURIA MACCONKEY/CLED #DM87 | Clinical Convenience Products, Inc. | 1980-02-13 | 9 | 0 |
| K792579 | CULTURIA MACCONKEY/COLUMBIA CNA | Clinical Convenience Products, Inc. | 1980-01-11 | 28 | 0 |
| K792284 | CULTURIA EMB/COLUMBIA CNA W/5% SHEEP | Clinical Convenience Products, Inc. | 1979-12-19 | 36 | 0 |
| K781370 | MS-2 AUTOMATED URINE SCREENING SYSTEM | Abbott Laboratories | 1978-09-20 | 43 | 0 |
| K781536 | VAC-U-PAC KIDNEY CASSETTE | E-Z-Em, Inc. | 1978-09-14 | 8 | 0 |
| K780803 | TILL-U-TEST, DIP SLIDE | Biotron , Ltd. | 1978-06-06 | 26 | 0 |
| K780021 | URINE SCREENING KITS | Diagnostic Culture System | 1978-03-17 | 72 | 0 |
| K780109 | TILL-U=TEST | Clinifax Industries, Ltd. | 1978-01-31 | 12 | 0 |
| K771672 | MICROCULT-ID | Miles Laboratories, Inc. | 1977-12-09 | 99 | 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