510(k) · Cleared
Recalled · Class II · 2022Pockit HSV 2 Rapid Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnology, Ltd. · LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
Cleared on Aug 19, 1999 after a 290-day review. The FDA summary names its predicate without a number. It has been recalled 3 times.
- Decided
- Aug 19, 1999
- Review
- 290 days
- Class
- Class II
- Product code
- LGC
- Recalls
- 3
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LGC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Gull HSV-2 IgG ELISA test Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 28, 2022 | Class II | Z-1021-2023 | Nonconforming Material/Component | HSV-2 rapid test may report false positive results. |
| Apr 14, 2010 | Not classified | Z-1970-2010 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | Negative serum was giving a positive result Herpes Simplex Type 2 (HSV-2). It is possible that misdiagnosis (i.e., positive) could be made. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All LGC devicesLGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LGC
FDA has decided no LGC device since 2007.
Median 510(k) review, days · LGC
Too few LGC 510(k)s in any year since 2007 to give a median.
Recalls per year · LGC
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LGC
1in 2024
MAUDE reports naming product code LGC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 1 | 4 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 4 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 1 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 1 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (232 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983886 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983886: Pockit HSV 2 Rapid Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983886
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026