510(k) Report

510(k) · Cleared

Cleared

Biotrack Monitor (Biotrack Reagent Cartridges)

K860720510(k) TraditionalCleared May 23, 198686-day reviewClass I21 CFR 862.2300

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

Biotrack, Inc. · JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

Cleared on May 23, 1986 after an 86-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
May 23, 1986
Review
86 days
Class
Class I
Product code
JJQ
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared1990200020102020
  1. This deviceK860720 Biotrack Monitor (Biotrack Reagent Cartridges)Biotrack, Inc. · 1986
  2. Descendant · cites it directly · 0 of its ownK983892 Coaguchek Pro System, Aptt Test Cartridges for Coaguchek Pro System…Roche Diagnostics/Boehringer Mannheim GmbH · 1999 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K983892Coaguchek Pro System, Aptt Test Cartridges for Coaguchek Pro System, Aptt Controls for…Roche Diagnostics/Boehringer Mannheim GmbH · 1999 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K860720Biotrack Monitor (Biotrack Reagent Cartridges)Biotrack, Inc.1986—
+1K983892Coaguchek Pro System, Aptt Test Cartridges for Coaguchek Pro System, Aptt…Roche Diagnostics/Boehringer Mannheim GmbH19991

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
FIG. 1 — Lineage of K860720, 1986–1999Source: 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 JJQ? 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K983892Coaguchek Pro System, Aptt Test Cartridges for Coaguchek Pro System, Aptt Controls for…Roche Diagnostics/Boehringer Mannheim GmbH19990

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, K983892 (Roche Diagnostics/Boehringer Mannheim GmbH, 1999) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JJQ devices

JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJQ

FDA has decided no JJQ device since 2007.

Median 510(k) review, days · JJQ

Too few JJQ 510(k)s in any year since 2007 to give a median.

Recalls per year · JJQ

1in 2025

2008: 22009: 12011: 12022: 12025: 1
2007high 2 (2008) · low 0 (2007)2026

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

Adverse event reports per year · JJQ

20in 2025

2007: 12008: 42009: 102010: 462011: 62012: 32013: 632014: 692015: 132016: 92017: 102018: 22019: 12021: 32022: 222023: 142024: 72025: 20
2007high 69 (2014) · low 0 (2020)2025

MAUDE reports naming product code JJQ, 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
20070—01
20080—24
20090—110
20100—046
20110—16
20120—03
20130—063
20140—069
20150—013
20160—09
20170—010
20180—02
20190—01
20200—00
20210—03
20220—122
20230—014
20240—07
20250—120
20260—0—

More from Biotrack, Inc.

16 FDA decisions under this applicant name. See the company

  • K934062Biotrack Therapeutic Drug-Monitoring Qual ControlsBiotrack, Inc. · 1993
  • K934061Biotrack Valproic Acid Test CartridgeBiotrack, Inc. · 1993
  • K920525Biotrack Therapeutic Drug Monitoring Qual. ControlBiotrack, Inc. · 1992
  • K915756Biotrack Carbamazepine Test CartridgeBiotrack, Inc. · 1992
  • K915755Biotrack Phenytoin Test CartridgeBiotrack, Inc. · 1992

Recent decisions in JJQ

The JJQ category page

  • K013371Ubit-IR300 Infrared Spectrometry SystemOtsuka Pharmaceutical Co., Ltd. · 20011 recall
  • K980120Digene DML 2000 Microplate LuminometerDigene Corp. · 19981 recall
  • K973938Alpha 4 LS Automated Microtiterplate Processor and ReaderSfri, Inc. · 1998
  • K974762Stat TracksAwareness Technology, Inc. · 1998
  • K962113Anthos Phacts Version Microplate ReaderColumbia Bioscience, Inc. · 1996

https://510kreport.com/device/K860720 · printed Nov 6, 2026

Cite this page

510(k) Report. “K860720: Biotrack Monitor (Biotrack Reagent Cartridges).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K860720

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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