510(k) Report

FDA applicant

Biosite Incorporated

San Diego, CA46 decisions1990–201035 recalls

FDA records 46 decisions for Biosite Incorporated (San Diego, CA) from 1990 to 2010: 45 510(k) clearances and 1 De Novo grant. Most are in product codes NBC (Test, Natriuretic Peptide) and DKZ (Enzyme Immunoassay, Amphetamine). Its devices cite 42 predicates, 25 of them its own earlier devices. 35 recalls are linked to its devices, 11 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Biosite Incorporated’s devices, and how often a recall has named them.

FDA decisions per year

2in 2010

2007: 32008: 12009: 12010: 2
2007high 3 (2007) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2023

2007: 12008: 12009: 52010: 12011: 22012: 9, 4 Class I2013: 12014: 7, 4 Class I2016: 3, 2 Class I2017: 12019: 12020: 22023: 1, 1 Class I
2007high 9 (2012) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Biosite Incorporated by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NBCTest, Natriuretic Peptide9decisions
  • DKZEnzyme Immunoassay, Amphetamine7decisions
  • JJYMulti-Analyte Controls, All Kinds (Assayed)6decisions
  • DIFDrug Mixture Control Materials4decisions
  • GGNPlasma, Coagulation Control2decisions
  • DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control2decisions

Also: JJX (2), DJR (2), LDJ (1), LDP (1), MCB (1), JHX (1).

Whose devices does it build on?

Its devices cite 42 predicates; 25 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 53 times; 25 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K021317Triage B-Type Natriuretic Peptide (BNP) TestBiosite Incorporated · 20026cite it
  • K973126Triage Cardiac Panel, Triage Troponin-I, Triage CK-MB, Triage Myoglobin, Triage Troponin-I and CK-MB, Triage…Biosite Incorporated · 19975cite it
  • K973547Triage StatmeterBiosite Incorporated · 19984cite it
  • K043242Triage Tox Drug ScreenBiosite Incorporated · 20053cite it
  • K051787Triage BNP Test, Model 98000XRBiosite Incorporated · 20053cite it
  • K040437Triage Profiler S.O.B. PanelBiosite Incorporated · 20042cite it

What has FDA decided for it lately?

  • K092987Inratio/INRATIO2 Test StripsBiosite Incorporated · 20106 Class I recalls
  • K092048One Step Eddp (Methadone Metabolite) Test StripBiosite Incorporated · 2010
  • K093032Triage Total 3 Controls and Calibration Verification SetBiosite Incorporated · 2009
  • K080269Triage Cardioprofiler and Profiler S.O.B. PanelsBiosite Incorporated · 20082 Class I recalls
  • K072892Triage Total Controls 5, Triage Total Calibration Verification 5Biosite Incorporated · 20075 recalls
  • K062840Triage Protein C Controls and Calibration Verification ControlsBiosite Incorporated · 2007
  • K062530Triage Protein C TestBiosite Incorporated · 2007
  • K060788Triage Tox Drug Screen Control Level 1 Model 94413 and Level 2 Model 94414Biosite Incorporated · 20062 recalls

All 46 as Biosite Incorporated →

What has been recalled?

35 recalls linked to its devices; the latest:

  • K030286Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-MB and…May 25, 2023Class I
  • K033383The Quidel Triage BNP CalibratorsOct 1, 2020Class II
  • K072892Control, Calibrator Verified, Triage BNP, Model ALR88755Jul 28, 2020Class II
  • K060788Quidel Triage TOX Drug Screen Control 1 Kit Box containing 5 Control 1 vials with 5 x…Apr 9, 2019Class II
  • K973784Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591; 25…Nov 14, 2017Class II
  • K072892Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the product: The…Oct 12, 2016Class II