# K121533: ST Aia-Pack Homocysteine; ST Aia-Pack Homocysteine Calibrator Set; Aia-Pack Homocysteine Control Set

- Pathway: 510(k) (Traditional)
- Applicant: Tosoh Bioscience, Inc.
- Decided: Jun 15, 2012 after 22 days
- Product code: LPS (Urinary Homocystine (Nonquantitative) Test System)
- Device class: 2
- Regulation: 21 CFR 862.1377
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003597 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003597: Immulite Homocysteine Model LKHO1 / Immulite 2000 Homocysteine Model L2KHO2, Diagnostic Products Corp. (2001) Summary page 1.

## Recalls of this device
- Nov 30, 2018 · Class II · Z-0675-2019: 
- Jun 5, 2018 · Class III · Z-2827-2018: Distribution of unapproved product labeling

## Indications for use
Reagents: ST AlA-PACK Homocysteine is designed for INVITRO DIAGNOSTIC USE ONLY for the quantitative measurement of homocysteine in human serum, heparinized plasma or EDTA plasma using a Tosoh AlA System Analyzer. Homocysteine. measurements are used inthe diagnosis and treatment of hyperhomocysteinemia or homocysteinuria. Calibrators: ST AlA-PACK Homocysteine Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST Alp PACK Homocysteine assay using a Tosoh AlA System Analyzer. Controls: The AlA-PACK Homocysteine Control Set is intended for INVITRO DIAGNOSTIC USE ONLY for performing quality control procedures with the ST AlA-PACK Homocysteine Assay.

Source page: https://510kreport.com/device/K121533
Methodology: https://510kreport.com/methodology