Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KLS — Predicate Candidate Screening
71 FDA 510(k) clearances under this product code; the 50 most recent screened below.
48 daysmedian FDA review time
140 days90th percentile
71clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K042520 | VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMA | Ortho-Clinical Diagnostics, Inc. | 2004-11-30 | 75 | 0 |
| K042407 | EMIT CAFFEINE ASSAY | Dade Behring, Inc. | 2004-10-28 | 55 | 0 |
| K020740 | ROCHE ONLINE THEOPHYLLINE | Roche Diagnostics Corp. | 2002-04-16 | 41 | 0 |
| K011771 | RANDOX THEOPHYLLINE | Randox Laboratories, Ltd. | 2002-01-17 | 225 | 0 |
| K013272 | ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY | Bayer Corp. | 2001-10-25 | 24 | 0 |
| K011166 | MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P22 | Syva Co., Dade Behring, Inc. | 2001-05-10 | 24 | 0 |
| K993029 | ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E | Syva Co. | 2000-01-27 | 140 | 0 |
| K973583 | ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS | Schiapparelli Biosystems, Inc. | 1997-11-12 | 51 | 0 |
| K972495 | ACCUMETER THEOPHYLLINE TEST | Chemtrak, Inc. | 1997-10-10 | 99 | 0 |
| K961462 | CEDIA THEOPHYLLINE ASSAY | Boehringer Mannheim Corp. | 1996-06-27 | 71 | 0 |
| K954569 | IMMULITE THEOPHYLLINE | Diagnostic Products Corp. | 1995-11-13 | 42 | 0 |
| K952596 | THEOPHYLLINE ENZYME IMMUNOASSAY | Diagnostic Reagents, Inc. | 1995-08-11 | 66 | 0 |
| K943979 | IL TEST THEOPHYLLINE | Instrumentation Laboratory CO | 1995-01-18 | 225 | 0 |
| K935373 | AXSYM THEOPHYLLINE | Abbott Laboratories | 1994-06-21 | 225 | 0 |
| K932685 | PARAMAX(R) THEOPHYLLINE REAGENT AND CALIBRATORS | Baxter Diagnostics, Inc. | 1993-09-24 | 113 | 0 |
| K933258 | VIDAS THEOPHYLLINE(THEO) | Biomerieux Vitek, Inc. | 1993-08-16 | 41 | 0 |
| K926245 | ABBOTT VISION THEOPHYLLINE IIA | Abbott Laboratories | 1993-05-06 | 143 | 0 |
| K913123 | EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS | Syva Co. | 1991-09-19 | 66 | 2 |
| K911060 | IMMUNOMATRIX THEOPHYLINE ASSAY SYSTEM | Immunomatrix | 1991-05-08 | 58 | 0 |
| K910697 | IL THEOPHYLLINE ASSAY SYSTEM | Instrumentation Laboratory CO | 1991-04-03 | 43 | 0 |
| K902243 | TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES | Technicon Instruments Corp. | 1990-07-05 | 48 | 0 |
| K901510 | ENZYMATIC THEOPHYLLINE REAGENT, #500-82 | Diagnostic Chemicals, Ltd. (Usa) | 1990-06-12 | 74 | 0 |
| K900373 | BIOTRACK THEOPHYLLINE TEST CARTRIDGE | Biotrack, Inc. | 1990-05-30 | 124 | 0 |
| K900009 | NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET | Kallestad Diag, A Div. of Erbamont, Inc. | 1990-03-29 | 86 | 0 |
| K896927 | VISION THEOPHYLLINE II | Abbott Laboratories | 1990-01-18 | 37 | 0 |
| K885253 | ACCULEVEL ONE-STEP THEOPHYLLINE TEST | Syva Co. | 1989-03-31 | 98 | 0 |
| K884358 | CEDIA THEOPHYLLINE ASSAY | Microgenics Corp. | 1989-02-07 | 113 | 0 |
| K890002 | COAT-A-COUNT (TM) THEOPHYLLINE | Diagnostic Products Corp. | 1989-01-23 | 20 | 0 |
| K885044 | BEHRING POLAROID OPUS THEOPHYLLINE | Pb Diagnostic Systems, Inc. | 1988-12-29 | 24 | 0 |
| K884002 | ANALYST THEOPHYLLINE ROTOR | The DU Pont Co. | 1988-10-31 | 40 | 0 |
| K881257 | EZ-BEAD THEOPHYLLINE ENZYME IMMUNOASSAY KIT | Immunotech Corp. | 1988-05-27 | 65 | 0 |
| K874578 | EMIT CONVENIENCE PACK: THEOPHYLLINE ASSAY | Syva Co. | 1987-11-24 | 18 | 0 |
| K873596 | BAKER TDM THEOPHYLLINE ASSAY | Baker Instructions Corp. | 1987-10-20 | 46 | 0 |
| K870736 | DART THEOPHYLLINE REAGENT SYSTEM | Coulter Electronics, Inc. | 1987-04-14 | 48 | 0 |
| K870952 | THEOPHYLLINE FPIA REAGENT SET | Sigma Diagnostics, Inc. | 1987-03-31 | 21 | 0 |
| K864041 | EMDS THEOPHYLLINE TESTPACKS ITEM #67662/95 | Em Diagnostic Systems, Inc. | 1986-11-25 | 40 | 0 |
| K862955 | METHODS FOR THE DIMENSION CLINICAL CHEM. SYSTEM | E.I. Dupont DE Nemours & Co., Inc. | 1986-09-25 | 51 | 0 |
| K862350 | EASY-TEST EMIT* THEOPHYLLINE(THEO) ITEM 67533/93 | Em Diagnostic Systems, Inc. | 1986-07-07 | 17 | 0 |
| K860464 | VISION THEOPHYLLINE - ADDIT. OF WHOLE BLOOD CLAIM | Abbott Laboratories | 1986-06-17 | 131 | 0 |
| K853872 | EMIT CAFFEINE ASSAY | Syva Co. | 1986-06-13 | 269 | 0 |
| K861367 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (THEO) | Eastman Kodak Company | 1986-05-29 | 48 | 1 |
| K855227 | MICRO-EIA THEOPHYLLINE TEST KIT MONOCLONAL | Bioclinical Systems, Inc. | 1986-04-11 | 102 | 0 |
| K854183 | IN VITRO TEST DETERMINATION OF THEOPHYLLINE | Clinical Data, Inc. | 1985-12-19 | 65 | 0 |
| K853834 | VISION THEOPHYLLINE | Abbott Laboratories | 1985-10-15 | 29 | 0 |
| K853858 | IL TEST THEOPHYLLINE ASSAY | Allied Instrumentation Laboratory | 1985-10-15 | 29 | 0 |
| K853372 | GEMSTAR IPA THEOPHYLLINE TEST KIT | Electro-Nucleonics Laboratories, Inc. | 1985-09-04 | 23 | 0 |
| K852573 | TECHNICON RA-1000 SYSTEM ANALYTE THEOPHYLLINE | Technicon Instruments Corp. | 1985-07-12 | 24 | 0 |
| K851741 | ACCULEVEL THEOPHYLLINE TEST(MODIFICATION) | Syva Co. | 1985-06-06 | 38 | 0 |
| K850856 | ICS THEOPHYLLINE REAGENTS | Beckman Instruments, Inc. | 1985-03-29 | 28 | 0 |
| K844642 | ACCULEVEL THEOPHYLLINE TEST | Syva Co. | 1985-03-19 | 111 | 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