510(k) · Cleared

Cleared

RNA1C Hemoglobin A1C Control for Bayer DCA2000 and DCA2000+ Analyzer

K050100510(k) TraditionalCleared Feb 25, 200538-day reviewClass I21 CFR 862.1660

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

Bionostics, Inc. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

Cleared on Feb 25, 2005 as substantially equivalent to K021484 (Canterbury Scientific, Ltd., 2002) after a 38-day review. Its family tree reaches back 2 generations to 1983.

Decided: Feb 25, 2005
Review: 38 days
Class: Class I
Product code: JJX
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K831478 (1983). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK831478 Lyphochek Hemoglobin Aic Control HumanBio-Rad · 1983
1 generation backK021484 Hemoglobin A1C ControlCanterbury Scientific, Ltd. · 2002 · Recalled
This deviceK050100 RNA1C Hemoglobin A1C Control for Bayer DCA2000 and DCA2000+ AnalyzerBionostics, Inc. · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K831478	Lyphochek Hemoglobin Aic Control Human	Bio-Rad	1983	—
−1	K021484	Hemoglobin A1C Control	Canterbury Scientific, Ltd.	2002	1
0 (this device)	K050100	RNA1C Hemoglobin A1C Control for Bayer DCA2000 and DCA2000+ Analyzer	Bionostics, Inc.	2005	—

FIG. 1 — Lineage of K050100, 1983–2005Source: 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 JJX? 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
*	K021484	Hemoglobin A1C Control Summary page 1 …A2000+ Analyzers is substantially equivalent in function, safety and efficacy to Bayer DCA 2000 Hemoglobin Al c Normal and Abnormal Control Kit. [K021484] Comparison of Technological Characteristics with Predicate Device Characteristic Ne…	Canterbury Scientific, Ltd.	2002	1

Also cleared against K021484: 1 other device →

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 22 years and passes through 3 companies; a new generation was cleared every 19.0 years on median.
1 of the 2 ancestors has a recall of any class.
1 other device also cites its predicate K021484.

How does its category compare?

All JJX devices

JJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJX

2in 2017

2007high 24 (2010) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJX

31in 2016

2007high 80 (2009) · low 30 (2014)2026

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

Recalls per year · JJX

1in 2021

2007high 3 (2007) · low 0 (2009)2026

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

Adverse event reports per year · JJX

22in 2025

2007high 82 (2019) · low 0 (2008)2025

MAUDE reports naming product code JJX, 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	6	53	3	2
2008	8	52	3	0
2009	17	80	0	1
2010	24	80	3	6
2011	19	62	2	62
2012	15	40	0	32
2013	19	37	0	51
2014	22	30	1	48
2015	11	65	1	67
2016	6	31	2	37
2017	2	—	0	19
2018	0	—	2	35
2019	0	—	0	82
2020	0	—	0	77
2021	0	—	1	43
2022	0	—	0	24
2023	0	—	0	22
2024	0	—	0	30
2025	0	—	0	22
2026	0	—	0	—

What is it indicated for?

RNAlc Control for Bayer DCA2000 and DCA2000+ Analyzers is intended to be used to

monitor and evaluate the analytical performance of the Bayer DCA 2000 and DCA 2000+

Analyzers that measure HbAlc. The use of quality control materials is indicated as an objective

assessment of the precision of methods and techniques in use and is an integral part of good

laboratory practice. The two levels of controls allow performance monitoring within the

clinically important range.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050100 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050100: RNA1C Hemoglobin A1C Control for Bayer DCA2000 and DCA2000+ Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050100

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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