510(k) · Cleared

Cleared

R&D Systems Body Fluid-I Hematology Control

K101578510(k) TraditionalCleared Apr 28, 2011325-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 Apr 28, 2011 as substantially equivalent to K053362 (Streck, 2006) after a 325-day review. Its family tree reaches back 3 generations to 2000.

Decided: Apr 28, 2011
Review: 325 days
Class: Class II
Product code: JPK
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K000076 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK000076 Cell-ChexStreck Laboratories, Inc. · 2000
2 generations backK051706 IQ Body Fluids ControlStreck · 2005
1 generation backK053362 Cell-Chex AutoStreck · 2006
This deviceK101578 R&D Systems Body Fluid-I Hematology ControlR&D Systems, Inc. · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K000076	Cell-Chex	Streck Laboratories, Inc.	2000	—
−2	K051706	IQ Body Fluids Control	Streck	2005	—
−1	K053362	Cell-Chex Auto	Streck	2006	—
0 (this device)	K101578	R&D Systems Body Fluid-I Hematology Control	R&D Systems, Inc.	2011	—

FIG. 1 — Lineage of K101578, 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 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
*	K053362	Cell-Chex Auto Summary page 1 …Hematology (81) Predicate Device Trade Name: Streck Cell-Chex'm Auto Hematology Control 510(k) number: K053362 Date: January 13mh, 2006 Descriition of Device The R&D Body Fluid-I is an assayed, in vitro, whole b…	Streck	2006	—

Also cleared against K053362: 2 other devices →

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 3 companies; a new generation was cleared every 5.3 years on median.
None of the 3 ancestors has a recall.
2 other devices also cite its predicate K053362.

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. 2011, 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?

The R&D Body Fluid-I Control is an assayed hematology control intended to monitor the reliability of hematology instruments that quantitatively measure red and white blood cell counts in cerebrospinal fluids, serous fluids, and synovial fluids.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K101578 · printed Nov 4, 2026

Cite this page

510(k) Report. “K101578: R&D Systems Body Fluid-I Hematology Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101578

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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