# K962373: N/T Rheumatology Control SL/1 and SL/2

- Pathway: 510(k) (Traditional)
- Applicant: Behring Diagnostics, Inc.
- Decided: Jul 11, 1996 after 21 days
- Product code: DCK (C-Reactive Protein, Antigen, Antiserum, And Control)
- Device class: 2
- Regulation: 21 CFR 866.5270
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
13 later devices descend from it; 6 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) N/T CRP Control Serum: named in the summary without a submission number
- (no number) N/T RF Control Serum: named in the summary without a submission number
- (no number) N/T ASL Control Serum: named in the summary without a submission number

## Most influential descendants
- K062035: Dimension Vista RF Flex Reagent Cartridge; Protein 2 Calibrator and Control (2006), 6 descendants of its own
- K063508: Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2 Calibrator and Control L, H; Protein 3 Calibrator an (2007), 5 descendants of its own
- K072435: Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1 Control M, 1 Control H (2007), 4 descendants of its own
- K083445: N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control LC (2009), 1 descendant of its own
- K073561: Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator (2008), 1 descendant of its own

## Indications for use
Accuracy control of the quantitative nephelometric and turbidimetric determination of ASL and CRP in the human serum using N Latex ASL and N Latex CRP mono Reagents or Turbiquant ASL and Turbiquant CRP respectively. In addition the product also serves as a accuracy control of the quantitative nephelometric determination of rheumatoid factors, and ADNase B* (only in N/T Rheumatology Control SL/2) in human serum using N Latex RF and N Latex ADNase B Reagent respectively.

Source page: https://510kreport.com/device/K962373
Methodology: https://510kreport.com/methodology