510(k) · Cleared

Cleared

XN Check BF

K160588510(k) TraditionalCleared Dec 22, 2016296-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 · JPK Mixture, Hematology Quality Control

Cleared on Dec 22, 2016 as substantially equivalent to K141957 (Streck, 2014) after a 296-day review. Its family tree reaches back 5 generations to 2000.

Decided: Dec 22, 2016
Review: 296 days
Class: Class II
Product code: JPK
Recalls: None
Predicates: 1

Its longest line of descent runs back 5 generations to K000076 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 5 generations backK000076 Cell-ChexStreck Laboratories, Inc. · 2000
4 generations backK051706 IQ Body Fluids ControlStreck · 2005
3 generations backK053362 Cell-Chex AutoStreck · 2006
2 generations backK120744 XN Check BFStreck · 2012
1 generation backK141957 XN Check BFStreck · 2014
This deviceK160588 XN Check BFStreck · 2016

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K000076	Cell-Chex	Streck Laboratories, Inc.	2000	—
−4	K051706	IQ Body Fluids Control	Streck	2005	—
−3	K053362	Cell-Chex Auto	Streck	2006	—
−2	K120744	XN Check BF	Streck	2012	—
−1	K141957	XN Check BF	Streck	2014	—
0 (this device)	K160588	XN Check BF	Streck	2016	—

FIG. 1 — Lineage of K160588, 2000–2016Source: 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

Get a 510(k) Report

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
*	K141957	XN Check BF Summary page 4 …Hematology quality control mixture (864.8625) Product Code: JPK Panel: Hematology Predicate Device: XN CHECK™ BF (K141957) Intended Use: XN CHECK BF is used for control and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21…	Streck	2014	—

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 16 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
None of the 5 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. 2016, 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?

XN CHECK BF is used for control and calibration verification of Sysmex XN series

(XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. It is not, however, intended for

actual calibration of these analyzers. Assayed parameters include:

WBC-BF (10"3/uL), RBC-BF (1076/uL), MN# (1073/uL), PMN# (1073/uL), MN%,

PMN%, TC-BF# (10"3/uL)

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/K160588 · printed Nov 6, 2026

Cite this page

510(k) Report. “K160588: XN Check BF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160588

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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