510(k) · Cleared

Cleared

Advia Testpoint CSF Control

K022968510(k) TraditionalCleared Sep 24, 200218-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

Bayer Diagnostics Corp. · JPK Mixture, Hematology Quality Control

Cleared on Sep 24, 2002 as substantially equivalent to K000076 (Streck Laboratories, Inc., 2000) after an 18-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.

Decided: Sep 24, 2002
Review: 18 days
Class: Class II
Product code: JPK
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 deviceK022968 Advia Testpoint CSF ControlBayer Diagnostics Corp. · 2002
Descendant · cites it directly · 0 of its ownK072846 CSF Automated Control, Models CSF001, CSF003R&D Systems, Inc. · 2007

Most influential descendants

Showing 1 of 1 · See all

K072846CSF Automated Control, Models CSF001, CSF003R&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
−1	K000076	Cell-Chex	Streck Laboratories, Inc.	2000	—
0 (this device)	K022968	Advia Testpoint CSF Control	Bayer Diagnostics Corp.	2002	—
+1	K072846	CSF Automated Control, Models CSF001, CSF003	R&D Systems, Inc.	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0

FIG. 1 — Lineage of K022968, 2000–2007Source: 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 JPK? 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 …a substantially equivalent determination for the ADVIA TESTpoint CSF Controls. Predicate Device Cell-Chex body fluid controls manufactured by Streck Laboratories, Inc (K000076). Intended Use ADVIA TESTpoint CSF Controls are hematology reference materials for monitoring the precision and accuracy of the…	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
K072846	CSF Automated Control, Models CSF001, CSF003	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?

Its one ancestor has no recall.
Of its descendants, K072846 (R&D Systems, Inc., 2007) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K000076.

How does its category compare?

All JPK devices

JPK Mixture, Hematology Quality Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JPK

4in 2016

2007high 5 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JPK

296in 2016

2007high 296 (2016) · low 44 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JPK

1in 2022

2007high 3 (2011) · low 0 (2008)2026

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

Adverse event reports per year · JPK

2in 2023

2007high 56 (2011) · low 0 (2009)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	5	44	1	14
2008	0	—	0	1
2009	5	187	0	0
2010	4	267	2	5
2011	1	—	3	56
2012	2	—	1	2
2013	1	—	0	0
2014	2	—	0	1
2015	0	—	0	0
2016	4	296	0	0
2017	0	—	0	0
2018	0	—	0	0
2019	0	—	0	1
2020	0	—	1	1
2021	0	—	2	1
2022	0	—	1	0
2023	0	—	0	2
2024	0	—	0	0
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

ADVIA TESTpoint CSF Controls are hematology reference materials for monitoring the precision and accuracy of the ADVIA 120 Hematology System when analyzing CSF samples.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022968 · printed Nov 5, 2026

Cite this page

510(k) Report. “K022968: Advia Testpoint CSF Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022968

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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