510(k) · Cleared

Cleared

Modification to N/T Rheumatology Controls SL 1 & 2

K021381510(k) TraditionalCleared Jun 10, 200240-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

Dade Behring, Inc. · JJY Multi-Analyte Controls, All Kinds (Assayed)

Cleared on Jun 10, 2002 as substantially equivalent to K962373 (Behring Diagnostics, Inc., 1996) after a 40-day review. Its family tree reaches back 1 generation to 1996.

Decided: Jun 10, 2002
Review: 40 days
Class: Class I
Product code: JJY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K962373 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK962373 N/T Rheumatology Control SL/1 and SL/2Behring Diagnostics, Inc. · 1996
This deviceK021381 Modification to N/T Rheumatology Controls SL 1 & 2Dade Behring, Inc. · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K962373	N/T Rheumatology Control SL/1 and SL/2	Behring Diagnostics, Inc.	1996	—
0 (this device)	K021381	Modification to N/T Rheumatology Controls SL 1 & 2	Dade Behring, Inc.	2002	—

FIG. 1 — Lineage of K021381, 1996–2002Source: 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 JJY? 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
*	K962373	N/T Rheumatology Control SL/1 and SL/2 Summary page 1 …Classification Number: Class I (862.1660) 3. Identification of the Legally Marketed Device: NPT Rheumatology Controls SL 1 & 2 (K962373) 4. Device Description: NPT Rheumatology Controls SL (bi-level control; NPT Rheumatology Control S U I and NPT…	Behring Diagnostics, Inc.	1996	—

Also cleared against K962373: 5 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?

Its one ancestor has no recall.
5 other devices also cite its predicate K962373.

How does its category compare?

All JJY devices

JJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJY

3in 2017

2007high 16 (2013) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJY

78in 2017

2007high 153 (2015) · low 40 (2012)2026

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

Recalls per year · JJY

2in 2025

2007high 6 (2010) · low 0 (2008)2026

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

Adverse event reports per year · JJY

13in 2025

2007high 20 (2012) · low 0 (2022)2025

MAUDE reports naming product code JJY, 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	11	49	5	2
2008	7	54	0	1
2009	8	80	2	3
2010	10	109	6	3
2011	14	120	1	6
2012	13	40	3	20
2013	16	82	2	5
2014	10	49	2	4
2015	4	153	1	4
2016	1	—	3	13
2017	3	78	4	12
2018	0	—	3	7
2019	0	—	4	1
2020	0	—	6	7
2021	0	—	0	1
2022	0	—	3	0
2023	0	—	3	4
2024	0	—	0	1
2025	0	—	2	13
2026	0	—	1	—

What is it indicated for?

NIT Rheumatology Controls are assayed controls for accuracy and precision in the quantitative determination of rheumatoid factors (RF), anti-streptolysin 0 (ASL) and C-reactive protein (CRP) in human serum using E” Systems and the TurbiTimeSystem.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021381 · printed Nov 5, 2026

Cite this page

510(k) Report. “K021381: Modification to N/T Rheumatology Controls SL 1 & 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021381

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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