# K223690: iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Yhlo Biotech Co., Ltd.
- Decided: Dec 11, 2023 after 367 days
- Product code: DHA (System, Test, Human Chorionic Gonadotropin)
- Device class: 2
- Regulation: 21 CFR 862.1155
- 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 K915195 (1992). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003178: Elecsys HCG and Beta Test System, Roche Diagnostics Corp. (2000) Summary page 5.
- K162606: Elecsys TSH assay, cobas e 801 Immunoassay analyzer, Roche Diagnostics (2017) Summary page 5.

## Indications for use
iFlash-HCG is a paramagnetic particle chemiluminescent immunoassay (CLIA) for quantitative detection of the intact human chorionic gonadotropin (hCG) molecule and the hCG β-subunit (β-hCG) in human serum and plasma using the automated Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C). The iFlash-HCG assay is to be used by laboratory professionals as an aid in early detection of pregnancy together with other clinical methods. Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) is a fully-automated, chemiluminescence immunoassay analyzer intended for quantitative or qualitative determination of analytes in human body fluids taken from clinical settings. It is used together with its supporting chemiluminescence immunoassay reagents. The Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) is intended for use in clinical laboratories.

Source page: https://510kreport.com/device/K223690
Methodology: https://510kreport.com/methodology