510(k) · Cleared

Cleared

CD-Chex Plus BC

K051633510(k) TraditionalCleared Aug 16, 200557-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 · GGL Control, White-Cell

Cleared on Aug 16, 2005 as substantially equivalent to K960894 (Streck Laboratories, Inc., 1996) after a 57-day review. Its family tree reaches back 2 generations to 1992. 1 later device descends from it.

Decided: Aug 16, 2005
Review: 57 days
Class: Class II
Product code: GGL
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K920997 (1992). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 2 generations backK920997 CD-ChexStreck Laboratories, Inc. · 1992
1 generation backK960894 CD-Chex + RBCStreck Laboratories, Inc. · 1996
This deviceK051633 CD-Chex Plus BCStreck · 2005
Descendant · cites it directly · 0 of its ownK083926 CD4 CountStreck · 2009

Most influential descendants

Showing 1 of 1 · See all

K083926CD4 CountStreck · 2009 · cites it directly0descendants

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)	K051633	CD-Chex Plus BC	Streck	2005	—
+1	K083926	CD4 Count	Streck	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0

FIG. 1 — Lineage of K051633, 1992–2009Source: 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 …lus BC Common Name: Immunophenotyping Control Classification Name: White Cell Control, 21CFR864.8625 Predicate Device: CD-Chex® Plus (K960894) Description: CD-Chex Plus BC is a suspension of stabilized human red blood cells and human white blood cells pack…	Streck Laboratories, Inc.	1996	—

Also cleared against K960894: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K083926	CD4 Count	Streck	2009	0

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 13 years and passes through 2 companies; a new generation was cleared every 9.2 years on median.
None of the 2 ancestors has a recall.
Of its descendants, K083926 (Streck, 2009) has gone furthest, with 0 descendants of its own.
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?

CD-Chex Plus BC is designed to serve as a quality control specimen for clinical flow-cytometric procedures performed with Beckman Coulter® flow cytometry instruments.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K051633 · printed Nov 5, 2026

Cite this page

510(k) Report. “K051633: CD-Chex Plus BC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051633

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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