# K100715: Audit Microcv Homocysteine Linearity Set, Model 704M-5

- Pathway: 510(k) (Traditional)
- Applicant: Aalto Scientific, Ltd.
- Decided: Dec 23, 2010 after 286 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: 3 generations back to K910440 (1991). 6 ancestors in all.
14 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984071: Liquichek Homocysteine Control, Cat #644, Bio-Rad (1998) Summary page 1.
- K042318: Audit Microcv General Chemistry Linearity Set, Aalto Scientific, Ltd. (2004) Summary page 1.

## Most influential descendants
- 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
- K141444: Immulite 2000; Cortisol Calibration Verification Material, Folic Acid Calibration Verification Material, Vitamin B12 Cal (2014), 1 descendant of its own

## Indications for use
The AuditTM MieroCVTM Homrocysteine Linearity Set is assayed quality control material consisting of five levels human based serum. Each level contains Honiocysteine analyte. The five levels demonstrate a linear relationship to each other for Homocysteine analyte. it is intended to simulate human patient serum samples for purpose of detenmining linearity, calibration verification and verification of reportable range for Hoiiocysteine. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling. The AuditTIM MicroCVTM Homocysteine Linearity Set should not be used for calibration or standardization of the Homocysteine assay. The AuditTM MicroCVTM1 Homocysteine Linearity Set is "For In Vitro Diagnostic Use Only".

Source page: https://510kreport.com/device/K100715
Methodology: https://510kreport.com/methodology