510(k) Report

510(k) · Cleared

Cleared

Meter Trax Trilevel, Low Level, Mid Level, High Level Trilevel Minipak

K042336510(k) TraditionalCleared Oct 14, 200445-day reviewClass II21 CFR 864.8625

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

Bio-Rad Laboratories, Inc. · JPK Mixture, Hematology Quality Control

Cleared on Oct 14, 2004 as substantially equivalent to K904461 (Hematronix, Inc., 1990) after a 45-day review. Its family tree reaches back 1 generation to 1990.

Decided
Oct 14, 2004
Review
45 days
Class
Class II
Product code
JPK
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K904461 (1990). No later device cites it as a predicate yet.

K904461 · Meter Trax · Hematronix, Inc. · 19901990199520002005
K904461 · Meter Trax · Hematronix, Inc. · 19900
  1. Root · 1 generation backK904461 Meter TraxHematronix, Inc. · 1990
  2. This deviceK042336 Meter Trax Trilevel, Low Level, Mid Level, High Level Trilevel MinipakBio-Rad Laboratories, Inc. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K904461Meter TraxHematronix, Inc.1990—
0 (this device)K042336Meter Trax Trilevel, Low Level, Mid Level, High Level Trilevel MinipakBio-Rad Laboratories, Inc.2004—
FIG. 1 — Lineage of K042336, 1990–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

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

Planning a device in JPK? 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
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K904461Meter Trax
Summary page 2
…age 2 of 2 Meter Trax TM Control 5.0 Comparison of the new device with the Predicate Device Meter Trax Control it substantial equivalent to Meter Trax (K904461) currently in commercial distribution The similarities and differences are listed below. Table 1. Similariti…
Hematronix, Inc.1990—

What descends from it?

No later submission names this one as a predicate yet.

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?

  • Its one ancestor has no recall.

How does its category compare?

All JPK devices

JPK Mixture, Hematology Quality Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JPK

4in 2016

2007: 52009: 52010: 42011: 12012: 22013: 12014: 22016: 4
2007high 5 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JPK

296in 2016

2007: 44 days median2009: 187 days median2010: 267 days median2016: 296 days median
2007high 296 (2016) · low 44 (2007)2026

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

Recalls per year · JPK

1in 2022

2007: 12010: 22011: 32012: 12020: 12021: 22022: 1
2007high 3 (2011) · low 0 (2008)2026

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

Adverse event reports per year · JPK

2in 2023

2007: 142008: 12010: 52011: 562012: 22014: 12019: 12020: 12021: 12023: 2
2007high 56 (2011) · low 0 (2009)2025

MAUDE reports naming product code JPK, 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
2007544114
20080—01
2009518700
2010426725
20111—356
20122—12
20131—00
20142—01
20150—00
2016429600
20170—00
20180—00
20190—01
20200—11
20210—21
20220—10
20230—02
20240—00
20250—00
20260—0—

What is it indicated for?

Meter Trax is an assayed whole blood control used in monitoring the precision of laboratory testing procedures for the analytes listed in this package insert.

The following parameters are listed in the package insert:

* Glucose

* Hemoglobin

* Hematoait

Indications for use as stated in the FDA summary.

More from Bio-Rad Laboratories, Inc.

103 FDA decisions under this applicant name. See the company

  • K181661QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR SystemBio-Rad Laboratories, Inc. · 20191 recall
  • K171664Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview SoftwareBio-Rad Laboratories, Inc. · 2017
  • K161687D-10 Hemoglobin A1c ProgramBio-Rad Laboratories, Inc. · 2016
  • K151321D-100 HbA1c, D-100 HbA1c Calibrator PackBio-Rad Laboratories, Inc. · 2015
  • K142448VARIANT II TURBO HbA1c Kit - 2.0Bio-Rad Laboratories, Inc. · 2015

Recent decisions in JPK

The JPK category page

  • K160590XN CheckStreck · 2016
  • K160588XN Check BFStreck · 2016
  • K160586XN-L CheckStreck · 2016
  • K160606BC-5D Hematology ControlR&D Systems, Inc. · 2016
  • K141964XN CheckStreck · 2014

https://510kreport.com/device/K042336 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042336: Meter Trax Trilevel, Low Level, Mid Level, High Level Trilevel Minipak.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042336

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026