# K000238: HSV-1 & HSV-2 Differentiation Immunoblot Igg, Model IB0900G

- Pathway: 510(k) (Traditional)
- Applicant: Mrl Diagnostics
- Decided: Apr 14, 2000 after 78 days
- Product code: LGC (Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific)
- Device class: 2
- Regulation: 21 CFR 866.3305
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
17 later devices descend from it; 14 cite 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K121895: Elecsys HSV-2 Igg Immunoassay (2012), 1 descendant of its own
- K120625: Elecsys HSV-1 Igg Immunoassay Elecsys Precicontrol HSV (2012), 1 descendant of its own
- K090409: Bioplex 2200 HSV-1 and HSV-2 Igg on the Bioplex 2200 Multi-Analyte Detection System (2009), 1 descendant of its own
- K243575: ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls (2025), 0 descendants of its own
- K213987: ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls (2023), 0 descendants of its own

## Recalls of this device
- Jul 6, 2007 · Not classified · Z-1764-2008: A small percentage of samples tested in specific lots, the HSV common antigen band appears lighter (less reactive) than the reading control band. Reduced reactivity of the common antigen band may lead

Source page: https://510kreport.com/device/K000238
Methodology: https://510kreport.com/methodology