# K021381: Modification to N/T Rheumatology Controls SL 1 & 2

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jun 10, 2002 after 40 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K962373 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962373: N/T Rheumatology Control SL/1 and SL/2, Behring Diagnostics, Inc. (1996) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K021381
Methodology: https://510kreport.com/methodology