# K990222: Immulite HCG, Model LKCG1, LCCG5, Immulite 2000 HCG, Model L2KCG2, L2KCG6

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Feb 26, 1999 after 32 days
- Product code: DHA (System, Test, Human Chorionic Gonadotropin)
- Device class: 2
- Regulation: 21 CFR 862.1155
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K911796 (1991). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911796: Immulite (TM) HCG, Cirrus Diagnostics, Inc. (1991) Summary page 2.

## Most influential descendants
- K042676: Nichols Advantage Hyperglycosylated Human Chorionic Gonadotropin (H-HCG) Assay (2004), 0 descendants of its own

## Recalls of this device
- Feb 22, 2022 · Class II · Z-1015-2022: Potential for falsely elevated hCG results due to sample carryover in serum and urine patient samples, as well as quality control samples and adjustors.

## Indications for use
IMMULITE HCG: For in vitro diagnostic use with the IMMULITE analyzer - for quantitative measurement of human chorionic gonadotropin (HCG) in serum, and for strictly qualitative determinations in urine, as an aid in the detection of pregnancy. IMMULITE 2000 HCG: For in vitro diagnostic use with the IMMULITE 2000 analyzer - for quantitative measurement of human chorionic gonadotropin (HCG) in serum, and for strictly qualitative determinations in urine, as an aid in the detection of pregnancy.

Source page: https://510kreport.com/device/K990222
Methodology: https://510kreport.com/methodology