510(k) · Cleared

Cleared

Cell-Chex

K101335510(k) TraditionalCleared Aug 23, 2010103-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 · GLQ Mixture, Control, White-Cell And Red-Cell Indices

Cleared on Aug 23, 2010 as substantially equivalent to K000076 (Streck Laboratories, Inc., 2000) after a 103-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.

Decided: Aug 23, 2010
Review: 103 days
Class: Class II
Product code: GLQ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K000076 (2000). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK000076 Cell-ChexStreck Laboratories, Inc. · 2000
This deviceK101335 Cell-ChexStreck · 2010
Descendant · cites it directly · 0 of its ownK110718 Cell-Chex with CPPD CrystalsStreck · 2011

Most influential descendants

Showing 1 of 1 · See all

K110718Cell-Chex with CPPD CrystalsStreck · 2011 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K000076	Cell-Chex	Streck Laboratories, Inc.	2000	—
0 (this device)	K101335	Cell-Chex	Streck	2010	—
+1	K110718	Cell-Chex with CPPD Crystals	Streck	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0

FIG. 1 — Lineage of K101335, 2000–2011Source: 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 GLQ? 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
*	K000076	Cell-Chex Summary page 1 …Name: Hematology Control for Body Fluids Classification Name: White and Red Blood Cell Control (864.8625) Predicate Device: Cell-CheXTM (K000076) Manufactured by Streck Description: Cell-Chex is a stabilized suspension of human red blood cells, human white blood cells and…	Streck Laboratories, Inc.	2000	—

Also cleared against K000076: 2 other devices →

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
K110718	Cell-Chex with CPPD Crystals	Streck	2011	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?

Its one ancestor has no recall.
Of its descendants, K110718 (Streck, 2011) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K000076.

How does its category compare?

All GLQ devices

GLQ Mixture, Control, White-Cell And Red-Cell Indices: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · GLQ

2in 2011

2007high 2 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GLQ

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

Recalls per year · GLQ

No recall names GLQ since 2007.

Adverse event reports per year · GLQ

No MAUDE report names GLQ since 2007.

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	1	—	0
2011	2	—	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	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

Cell-Chex is an assayed control intended for monitoring total cell counts performed manually using a hemocytometer to validate quantitation of red and white blood cells in patient cerebrospinal fluid and body fluid samples including pleural, pericardial, peritoneal and synovial fluid. Level 1 contains monosodium urate crystals which can be used to monitor the presence of crystals in synovial fluid.

Cell-Chex is also intended for monitoring white blood cell differentiation (Mononuclear, Polymorphonuclear; Neutrophils, Eosinophils, Basophils, Lymphocytes and Monocytes) in body fluid samples performed using Cytospin® smears

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K101335 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101335: Cell-Chex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101335

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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