510(k) · Cleared

Cleared

CSF Automated Control, Models CSF001, CSF003

K072846510(k) TraditionalCleared Nov 26, 200753-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

R&D Systems, Inc. · JPK Mixture, Hematology Quality Control

Cleared on Nov 26, 2007 as substantially equivalent to K022968 (Bayer Diagnostics Corp., 2002) after a 53-day review. Its family tree reaches back 2 generations to 2000.

Decided: Nov 26, 2007
Review: 53 days
Class: Class II
Product code: JPK
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 backK022968 Advia Testpoint CSF ControlBayer Diagnostics Corp. · 2002
This deviceK072846 CSF Automated Control, Models CSF001, CSF003R&D Systems, Inc. · 2007

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	K022968	Advia Testpoint CSF Control	Bayer Diagnostics Corp.	2002	—
0 (this device)	K072846	CSF Automated Control, Models CSF001, CSF003	R&D Systems, Inc.	2007	—

FIG. 1 — Lineage of K072846, 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
*	K022968	Advia Testpoint CSF Control Summary page 1 …oduct Code: JPK Device Class: II Panel: Hematology (81) Predicate Device Bayer Diagnostics (now Siemens) ADVIA TESTpoint CSF Controls (K022968) Description of Device CSF AUTOMATED CONTROL is an in vitro diagnostic reagent composed of human erythrocytes and bovine leukocy…	Bayer Diagnostics Corp.	2002	—

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 7 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
None of the 2 ancestors has a recall.

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. 2007, this device’s year, is highlighted.

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?

CSF AUTOMATED CONTROLS is an assayed control designed to monitor values obtained using hematology instruments that measure CSF samples.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K072846 · printed Nov 4, 2026

Cite this page

510(k) Report. “K072846: CSF Automated Control, Models CSF001, CSF003.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072846

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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