# K983886: Pockit HSV 2 Rapid Test

- Pathway: 510(k) (Traditional)
- Applicant: Diagnology, Ltd.
- Decided: Aug 19, 1999 after 290 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: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Gull HSV-2 IgG ELISA test: named in the summary without a submission number

## Recalls of this device
- Sep 28, 2022 · Class II · Z-1021-2023: HSV-2 rapid test may report false positive results.
- Apr 14, 2010 · Not classified · Z-1970-2010: Negative serum was giving a positive result Herpes Simplex Type 2 (HSV-2). It is possible that misdiagnosis (i.e., positive) could be made.
- Apr 14, 2010 · Not classified · Z-1971-2010: Negative serum was giving a positive result Herpes Simplex Type 2 (HSV-2). It is possible that misdiagnosis (i.e., positive) could be made.

## Indications for use
The POCKIt™ HSV-2 Rapid Test is a single unit, membrane-based immunoassay for the qualitative determination, either in heparinized capillary whole blood taken by fingerstick or in serum, of circulating IgG antibodies specific for herpes simplex virus type 2 (HSV-2), which arise as a result of infection with HSV-2. It is intended for in-vitro diagnostic use by health professionals in Point of Care testing. The presence of antibodies to HSV-2 may be indicative of a previous infection with HSV-2 and may be of value in determination of previous immunological experience and to aid in the diagnosis of HSV associated disease. This assay will not differentiate whether infection is currently in a latent or active state. PRECAUTION: The POCkit™ HSV-2 Rapid Test is intended for use in a high prevalence population, e.g. sexually active adults and sexually transmitted disease clinic. If used in a low prevalence population, positive results should be considered presumptive and should be confirmed with an altemnate methodology e.g. Waestern blot. Assay resulls are not intended for medicalflegal use. The POCKkit™ HSV-2 Rapid Test is not recommended as a screening procedure for the general population of for testing In a prenatal, pediatric or neonatal population. Performance characteristics have not been established in a low prevalence population e.g. prenatal patients, on Immunocompromised individuals, for prenatal or neonatal screening, on other patients with HSV associated diseases, or for earty stages of HSV seroconversion.

Source page: https://510kreport.com/device/K983886
Methodology: https://510kreport.com/methodology