# K984477: Lyphochek Whole Blood Metals Control Levels 1,2,3, Models 527, 528, 529

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Jan 29, 1999 after 44 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: 2 generations back to K895905 (1990). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980871: Lyphochek Whole Blood Control, Bio-Rad (1998). Our OCR of the scanned summary read K380871, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Lyphochek Whole Blood Control”.

## Most influential descendants
- K020610: Lyphochek Whole Blood Metals Control Model # 527, 528, 529 (2002), 0 descendants of its own

## Indications for use
Lyphochek Whole Blood Metals Control is intended for use as an assayed quality control to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Source page: https://510kreport.com/device/K984477
Methodology: https://510kreport.com/methodology