510(k) · Cleared

Cleared

Sickle-Chex

K013316510(k) TraditionalCleared Nov 6, 200133-day reviewClass II21 CFR 864.7825

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

Streck Laboratories, Inc. · GHM Test, Sickle Cell

Cleared on Nov 6, 2001 after a 33-day review. The FDA summary names no predicate by number. 1 later device descends from it.

Decided: Nov 6, 2001
Review: 33 days
Class: Class II
Product code: GHM
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK013316 Sickle-ChexStreck Laboratories, Inc. · 2001
Descendant · cites it directly · 0 of its ownK070334 R&D Sickle QC ControlR&D Systems, Inc. · 2007

Most influential descendants

Showing 1 of 1 · See all

K070334R&D Sickle QC ControlR&D Systems, Inc. · 2007 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K013316	Sickle-Chex	Streck Laboratories, Inc.	2001	—
+1	K070334	R&D Sickle QC Control	R&D Systems, Inc.	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0

FIG. 1 — Lineage of K013316, 2001–2007Source: 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 GHM? 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?

The FDA summary names no predicate by number.

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
K070334	R&D Sickle QC Control	R&D Systems, Inc.	2007	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?

Of its descendants, K070334 (R&D Systems, Inc., 2007) has gone furthest, with 0 descendants of its own.

How does its category compare?

All GHM devices

GHM Test, Sickle Cell: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GHM

FDA has decided no GHM device since 2007.

Median 510(k) review, days · GHM

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

Recalls per year · GHM

3in 2012

2007high 3 (2012) · low 0 (2007)2026

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

Adverse event reports per year · GHM

No MAUDE report names GHM since 2007.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	0	0
2010	—	0	0
2011	—	0	0
2012	—	3	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?

Sickle-Chex is intended to be used as a sickle cell control in testing for the presence of hemoglobin S in solubility tests and hemoglobin electrophoresis.

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/K013316 · printed Nov 4, 2026

Cite this page

510(k) Report. “K013316: Sickle-Chex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013316

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026