510(k) · Cleared

Cleared

CD-Chex CD 34

K993126510(k) TraditionalCleared Nov 26, 199967-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

Streck Laboratories, Inc. · GGL Control, White-Cell

Cleared on Nov 26, 1999 as substantially equivalent to K960894 (Streck Laboratories, Inc., 1996) after a 67-day review. Its family tree reaches back 2 generations to 1992.

Decided: Nov 26, 1999
Review: 67 days
Class: Class II
Product code: GGL
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K920997 (1992). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK920997 CD-ChexStreck Laboratories, Inc. · 1992
1 generation backK960894 CD-Chex + RBCStreck Laboratories, Inc. · 1996
This deviceK993126 CD-Chex CD 34Streck Laboratories, Inc. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K920997	CD-Chex	Streck Laboratories, Inc.	1992	—
−1	K960894	CD-Chex + RBC	Streck Laboratories, Inc.	1996	—
0 (this device)	K993126	CD-Chex CD 34	Streck Laboratories, Inc.	1999	—

FIG. 1 — Lineage of K993126, 1992–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 GGL? 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.

Type	Number	Device	Applicant	Decided	Recalls
*	K960894	CD-Chex + RBC Summary page 1 …Names of Device: Trade Name: CD Chex CD 34 Common Name: Immunophenotyping Control Classification Name: White Cell Control §864.8625 Predicate Device: CD Chex Plus RBC (K960894) manufactured by Streck Laboratories Description: CD Chex CD 34 is a stabilized suspension of human placental blood containing r…	Streck Laboratories, Inc.	1996	—

Also cleared against K960894: 1 other device →

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?

The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 4.0 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K960894.

How does its category compare?

All GGL devices

GGL Control, White-Cell: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GGL

1in 2009

2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GGL

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

Recalls per year · GGL

No recall names GGL since 2007.

Adverse event reports per year · GGL

1in 2023

2007high 1 (2023) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	1	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	1
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

A clinical laboratory performing quantitative stem cell analysis needs a control specimen for verifying the measurement process. CD Chex CD 34 is such a specimen. It consists of stabilized placental blood containing a population of CD 34 positive stem cells. It is used as a procedural control for monitoring monoclonal antibody binding in flow cytometry methods. Users of Becton Dickinson ProCount Progenitor Cell Enumeration Kit or ISHAGE protocol can validate their CD 34 results by controlling the procedure with CD Chex CD 34.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K993126 · printed Nov 6, 2026

Cite this page

510(k) Report. “K993126: CD-Chex CD 34.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993126

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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