Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Biosite Incorporated — Predicate Candidate Screening

46 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

74 daysmedian FDA review time

160 days90th percentile

46clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K092987	INRATIO/INRATIO2 TEST STRIPS	Biosite Incorporated	2010-06-11	256	7
K092048	ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP	Biosite Incorporated	2010-04-19	286	0
K093032	TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET	Biosite Incorporated	2009-11-13	45	0
K080269	TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS	Biosite Incorporated	2008-06-06	126	4
K072892	TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATI	Biosite Incorporated	2007-12-07	58	4
K062840	TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTR	Biosite Incorporated	2007-03-01	160	0
K062530	TRIAGE PROTEIN C TEST	Biosite Incorporated	2007-01-29	153	0
K060788	TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL	Biosite Incorporated	2006-07-10	109	1
K060791	TRIAGE TOX DRUG SCREEN, MODEL 94400	Biosite Incorporated	2006-06-22	91	5
K052789	TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MOD	Biosite Incorporated	2006-01-23	112	1
K051787	TRIAGE BNP TEST, MODEL 98000XR	Biosite Incorporated	2005-09-22	83	0
K050799	TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS; TRIAGE(	Biosite Incorporated	2005-06-29	91	0
K050037	TRIAGE TOX DRUG SCREEN CONTROLS	Biosite Incorporated	2005-03-22	74	0
K043242	TRIAGE TOX DRUG SCREEN	Biosite Incorporated	2005-02-28	97	1
K042723	TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300	Biosite Incorporated	2004-12-07	67	0
K042890	TRIAGE D-DIMER TEST, MODEL 98100	Biosite Incorporated	2004-11-29	41	2
K040459	TRIAGE PROFILER S.O.B. CONTROLS AND S.O.B. CALIBRATION VERIF	Biosite Incorporated	2004-07-06	134	0
K040437	TRIAGE PROFILER S.O.B. PANEL	Biosite Incorporated	2004-06-25	127	0
K032235	MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST	Biosite Incorporated	2004-01-28	191	0
K033383	TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS,	Biosite Incorporated	2003-12-23	61	0
K030286	TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL	Biosite Incorporated	2003-02-21	24	3
K030089	TRIAGE CARDIAC CONTROLS; TRIAGE CARDIO PROFILER CONTROLS	Biosite Incorporated	2003-01-23	13	0
K030088	TRIAGE CARDIAC CALIBRATION VERIFICATION CONTROLS, TRIAGE CAR	Biosite Incorporated	2003-01-17	7	0
K021317	TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST	Biosite Incorporated	2002-07-01	67	0
K014247	TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002	Biosite Incorporated	2002-06-03	159	0
K012745	TRIAGE TOX DRUG SCREEN, CATALOG #94000	Biosite Incorporated	2002-01-10	147	0
K012999	TRIAGE TOX DRUG SCREEN CONTROLS, CATALOG #94001	Biosite Incorporated	2001-10-03	27	0
K013002	TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CA	Biosite Incorporated	2001-10-03	27	0
K010266	TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000	Biosite Incorporated	2001-03-16	46	0
DEN000010	TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST	Biosite Incorporated	2000-11-20	5	0
K000231	TRIAGE BNP CALIBRATION VERIFICATION CONTROLS	Biosite Incorporated	2000-03-02	35	0
K000230	TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) CONTROLS	Biosite Incorporated	2000-02-29	33	0
K982245	TRIAGE,PARASITE PANEL, TRIAGE CRYPTOSPORIDIUM AND ENTAMOEBA	Biosite Incorporated	1998-10-06	102	0
K974881	TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DI	Biosite Incorporated	1998-03-20	80	1
K973547	TRIAGE STATMETER	Biosite Incorporated	1998-01-13	117	0
K974827	TRIAGE(R) CARDIAC PANEL CALIBRATION VERIFICATION CONTROLS, T	Biosite Incorporated	1998-01-08	15	0
K974461	TRIAGE CARDIAC CONTROLS, TRIAGE TROPONIN-I CONTROL, TRIAGE C	Biosite Incorporated	1997-12-10	15	0
K973784	TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSA	Biosite Incorporated	1997-12-03	61	3
K973126	TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAG	Biosite Incorporated	1997-10-06	47	0
K955934	TRIAGE PANEL FOR DRUGS OF ABUSE MODEL 9500/93000	Biosite Incorporated	1996-02-16	65	0
K955935	TRIAGE PANEL FOR DRUGS OF ABUSE/TRICYCLIC ANTIDEPRESSANTS	Biosite Incorporated	1996-02-15	64	0
K934340	BIOSITE DIAGNOSTICS - TRIAGE PANEL FOR DRUGS OF ABUSE PLUS T	Biosite Incorporated	1994-12-02	450	0
K931598	BIOSITE TRIAGE PANEL FOR DRUGS OF ABUSE(50NG/ML)	Biosite Incorporated	1993-05-12	41	0
K924476	THE TRIAGE II	Biosite Incorporated	1993-01-22	141	1
K914146	BIOSITE DIAGNOSTICS-TRIAGE PANEL FOR DRUGS ABUSE	Biosite Incorporated	1991-10-11	25	0
K902924	BIOSITE DIAGNOSTICS OPIATE SCREENING TEST	Biosite Incorporated	1990-09-14	74	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