# K972608: Randox Assayed Specific Protein Control

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Aug 4, 1997 after 54 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Nov 22, 2022 · Class II · Z-0903-2023: Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range
- Nov 22, 2022 · Class II · Z-0904-2023: Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range
- Nov 22, 2022 · Class II · Z-0905-2023: Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range
- May 22, 2018 · Class II · Z-2279-2018: The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein Controls increase over the shelf life of the product. This may lead to a delay in reporting Free Kappa 
- May 22, 2018 · Class II · Z-2278-2018: The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein Controls increase over the shelf life of the product. This may lead to a delay in reporting Free Kappa 
- May 22, 2018 · Class II · Z-2280-2018: The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein Controls increase over the shelf life of the product. This may lead to a delay in reporting Free Kappa 

## Indications for use
The Randox Laboratories Limited Specific Protein Control Serum (Low and Elevated) are based on lyophilised human serum and have been developed for the control of both accuracy and precision in clinical chemistry applications, particularly specific protein analysis. These control materials are available at two constituent concentrations. The Randox Specific Protein Controls should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Source page: https://510kreport.com/device/K972608
Methodology: https://510kreport.com/methodology