# K984071: Liquichek Homocysteine Control, Cat #644

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Dec 3, 1998 after 17 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- 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 K980812 (1998). 2 ancestors in all.
15 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980907: Axis Homocysteine Enzyme Immunoassay, Axis Biochemicals, Asa (1998) Summary page 1.
- K980812: Imx Homocysteine, Axis Biochemicals, Asa (1998) Summary page 1.

## Most influential descendants
- K100715: Audit Microcv Homocysteine Linearity Set, Model 704M-5 (2010), 14 descendants of its own
- K133128: Immulite 2000; HCG Calibration Verification Material, Insulin Calibration Verification Material, Pyrilinks-D Calibration (2013), 13 descendants of its own
- K140258: Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH Calibration Verification Material (2014), 7 descendants of its own
- K140818: Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I Calibration Verification Material, 2000 Prolactin C (2014), 3 descendants of its own
- K140541: Immulite 2000: C-Peptide Calibration Verification Material, SHBG Calibration Verification Material, Total Testosterone C (2014), 2 descendants of its own

## Indications for use
Liquichek Homocysteine Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for homocysteine.

Source page: https://510kreport.com/device/K984071
Methodology: https://510kreport.com/methodology