510(k) · Cleared

Cleared

Cell-Chex with CPPD Crystals

K110718510(k) TraditionalCleared May 26, 201172-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 May 26, 2011 as substantially equivalent to K101335 (Streck, 2010) after a 72-day review. Its family tree reaches back 2 generations to 2000.

Decided: May 26, 2011
Review: 72 days
Class: Class II
Product code: GLQ
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K000076 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK000076 Cell-ChexStreck Laboratories, Inc. · 2000
1 generation backK101335 Cell-ChexStreck · 2010
This deviceK110718 Cell-Chex with CPPD CrystalsStreck · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K000076	Cell-Chex	Streck Laboratories, Inc.	2000	—
−1	K101335	Cell-Chex	Streck	2010	—
0 (this device)	K110718	Cell-Chex with CPPD Crystals	Streck	2011	—

FIG. 1 — Lineage of K110718, 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
*	K101335	Cell-Chex Summary page 1 …e: Hematology Control for Body Fluids Classification Name: Hematology Quality Control Mixture (864.8625) Predicate Device: Cell-Chex TM (K1 01335) Manufactured by Streck Description: Cell-ChexTM with CPPD Crystals is a stabilized suspension of human red blood cells, human…	Streck	2010	—

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 11 years and passes through 2 companies; a new generation was cleared every 10.5 years on median.
None of the 2 ancestors has a recall.

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. 2011, 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?

CelI-ChexTM with CPPD Crystals 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, pericardlial, peritoneal and synovial fluid. Level 1 contains calcium pyrophosphate dlihydrate (CPPD) Crystals, which can be used to monitor the presence of crystals in synovial fluid.

CellCheXTM with CPPID Crystals 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/K110718 · printed Nov 3, 2026

Cite this page

510(k) Report. “K110718: Cell-Chex with CPPD Crystals.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K110718

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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