510(k) Report

510(k) · Cleared

Recalled · Class II · 2022

chromID Strepto B agar

K163042510(k) TraditionalCleared Jan 27, 201788-day reviewClass I21 CFR 866.2360Recalls 1

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

bioMerieux, Inc. · PQZ Gbs Culture Media, Selective And Differential

Cleared on Jan 27, 2017 as substantially equivalent to K881577 (Acumedia Manufacturers, Inc., 1988) after an 88-day review. Its family tree reaches back 1 generation to 1988. 1 later device descends from it. It has been recalled once.

Decided
Jan 27, 2017
Review
88 days
Class
Class I
Product code
PQZ
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K881577 (1988). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2018: 1 descendant clearedK881577 · Modified Selective Streptococcus Agar · Acumedia Manufacturers, Inc. · 19881990200020102020
Descendants, by generation 1 generation forward: 1 descendant K881577 · Modified Selective Streptococcus Agar · Acumedia Manufacturers, Inc. · 19880
  1. Root · 1 generation backK881577 Modified Selective Streptococcus AgarAcumedia Manufacturers, Inc. · 1988
  2. This deviceK163042 chromID Strepto B agarbioMerieux, Inc. · 2017
  3. Descendant · cites it directly · 0 of its ownK173903 Granada MediumHardy Diagnostics · 2018

Most influential descendants

Showing 1 of 1 · See all
  • K173903Granada MediumHardy Diagnostics · 2018 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K881577Modified Selective Streptococcus AgarAcumedia Manufacturers, Inc.1988—
0 (this device)K163042chromID Strepto B agarbioMerieux, Inc.2017—
+1K173903Granada MediumHardy Diagnostics2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
FIG. 1 — Lineage of K163042, 1988–2018Source: 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), 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 PQZ? 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? (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
*K881577Modified Selective Streptococcus Agar
Summary page 4
…Selective culture medium Product Code PQZ Common Name: Selective Culture Media C. Predicate Device: Modified Selective Streptococcus Agar (K881577) D. 510(k) Summary: Intended Use: chromID® Strepto B agar is a selective chromogenic medium that is intended to aid in the qual…
Acumedia Manufacturers, Inc.1988—

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K173903Granada MediumHardy Diagnostics20180

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

Recalls of this device

DateClassRecallRoot causeReason
Nov 9, 2022Class IIZ-0847-2023StorageAs the temperature and time out of range was exceeded, product performances cannot be guaranteed

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K173903 (Hardy Diagnostics, 2018) has gone furthest, with 0 descendants of its own.

How does its category compare?

All PQZ devices

PQZ Gbs Culture Media, Selective And Differential: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · PQZ

1in 2018

2017: 32018: 1
2007high 3 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PQZ

88in 2017

2017: 88 days median
2007high 88 (2017)2026

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

Recalls per year · PQZ

1in 2022

2020: 12022: 1
2007high 1 (2020) · low 0 (2007)2026

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

Adverse event reports per year · PQZ

2in 2018

2017: 22018: 2
2007high 2 (2017) · low 0 (2007)2025

MAUDE reports naming product code PQZ, 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—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
201738802
20181—02
20190—00
20200—10
20210—00
20220—10
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

chromID® Strepto B agar is a selective chromogenic medium that is intended to aid in the qualitative determination of Group B Streptococcus (GBS) colonization in pregnant women. This medium supports the growth of, but does not differentiate between, hemolytic and non-hemolytic GBS strains. The test is performed on 18-24 hour LIM broth enrichments of vaginal/rectal swabs obtained from pregnant women. chromID® Strepto B agar results can be interpreted…

Read the full statement (136 words)

chromID® Strepto B agar is a selective chromogenic medium that is intended to aid in the qualitative determination of Group B Streptococcus (GBS) colonization in pregnant women. This medium supports the growth of, but does not differentiate between, hemolytic and non-hemolytic GBS strains. The test is performed on 18-24 hour LIM broth enrichments of vaginal/rectal swabs obtained from pregnant women. chromID® Strepto B agar results can be interpreted after 24 hours incubation with confirmation of characteristic GBS colonies from the media.

chromID® Strepto B agar is not intended to diagnose infection nor to guide or monitor treatment for infections. chromID® Strepto B agar does not provide susceptibility results. Subculture to non-selective media should be performed as needed for susceptibility testing. chromID® Strepto B agar is intended for use by laboratory health practitioners in a clinical laboratory.

Indications for use as stated in the FDA summary.

More from bioMerieux, Inc.

281 FDA decisions under this applicant name. See the company

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  • K260160VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystembioMerieux, Inc. · 2026
  • K260282VITEK 2 AST-Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc. · 2026
  • K251579VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)bioMerieux, Inc. · 2025
  • K234012Vitek Compact ProbioMerieux, Inc. · 2025

Recent decisions in PQZ

The PQZ category page

  • K173903Granada MediumHardy Diagnostics · 2018
  • K170586Strep B Carrot Broth One-StepHardy Diagnostics · 20172 recalls
  • K170481Strep B Carrot Broth KitHardy Diagnostics · 2017

https://510kreport.com/device/K163042 · printed Nov 6, 2026

Cite this page

510(k) Report. “K163042: chromID Strepto B agar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163042

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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