510(k) Report

510(k) · Cleared

Cleared

Triage BNP Calibration Verification Controls

K000231510(k) TraditionalCleared Mar 2, 200035-day reviewClass I21 CFR 862.1660

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biosite Incorporated · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

Cleared on Mar 2, 2000 after a 35-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.

Decided
Mar 2, 2000
Review
35 days
Class
Class I
Product code
JJX
Recalls
None
Predicates
0

4 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2004: 1 descendant cleared2007: 1 descendant cleared2009: 1 descendant cleared200020052010201520202025
  1. This deviceK000231 Triage BNP Calibration Verification ControlsBiosite Incorporated · 2000
  2. Descendant · cites it directly · 3 of its ownK030088 Triage Cardiac Calibration Verification Controls, Triage Cardio…Biosite Incorporated · 2003
  3. Descendant · 2 generations on · 2 of its ownK040459 Triage Profiler S.O.B. Controls and S.O.B. Calibration Verification…Biosite Incorporated · 2004
  4. Descendant · 3 generations on · 1 of its ownK072892 Triage Total Controls 5, Triage Total Calibration Verification 5Biosite Incorporated · 2007 · Recalled
  5. Descendant · 4 generations on · 0 of its ownK093032 Triage Total 3 Controls and Calibration Verification SetBiosite Incorporated · 2009

Most influential descendants

Showing 4 of 4 · See all
  • K030088Triage Cardiac Calibration Verification Controls, Triage Cardio Profiler Calibration…Biosite Incorporated · 2003 · cites it directly3descendants
  • K040459Triage Profiler S.O.B. Controls and S.O.B. Calibration Verification ControlsBiosite Incorporated · 2004 · 2 generations on2descendants
  • K072892Triage Total Controls 5, Triage Total Calibration Verification 5Biosite Incorporated · 2007 · 3 generations on1descendant
  • K093032Triage Total 3 Controls and Calibration Verification SetBiosite Incorporated · 2009 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000231Triage BNP Calibration Verification ControlsBiosite Incorporated2000—
+1K030088Triage Cardiac Calibration Verification Controls, Triage Cardio Profiler…Biosite Incorporated2003—
+2K040459Triage Profiler S.O.B. Controls and S.O.B. Calibration Verification ControlsBiosite Incorporated2004—
+3K072892Triage Total Controls 5, Triage Total Calibration Verification 5Biosite Incorporated20075
+4K093032Triage Total 3 Controls and Calibration Verification SetBiosite Incorporated2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200410
200710
200910
FIG. 1 — Lineage of K000231, 2000–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JJX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (4)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K030088Triage Cardiac Calibration Verification Controls, Triage Cardio Profiler Calibration…Biosite Incorporated20033

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K030088 (Biosite Incorporated, 2003) has gone furthest, with 3 descendants of its own.

How does its category compare?

All JJX devices

JJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJX

2in 2017

2007: 62008: 82009: 172010: 242011: 192012: 152013: 192014: 222015: 112016: 62017: 2
2007high 24 (2010) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJX

31in 2016

2007: 53 days median2008: 52 days median2009: 80 days median2010: 80 days median2011: 62 days median2012: 40 days median2013: 37 days median2014: 30 days median2015: 65 days median2016: 31 days median
2007high 80 (2009) · low 30 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JJX

1in 2021

2007: 32008: 32010: 32011: 22014: 12015: 12016: 22018: 22021: 1
2007high 3 (2007) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JJX

22in 2025

2007: 22009: 12010: 62011: 622012: 322013: 512014: 482015: 672016: 372017: 192018: 352019: 822020: 772021: 432022: 242023: 222024: 302025: 22
2007high 82 (2019) · low 0 (2008)2025

MAUDE reports naming product code JJX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200765332
200885230
2009178001
2010248036
20111962262
20121540032
20131937051
20142230148
20151165167
2016631237
20172—019
20180—235
20190—082
20200—077
20210—143
20220—024
20230—022
20240—030
20250—022
20260—0—

More from Biosite Incorporated

46 FDA decisions under this applicant name. See the company

  • 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

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https://510kreport.com/device/K000231 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000231: Triage BNP Calibration Verification Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000231

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026