510(k) · Cleared
ClearedImmulite Herpes I and II Igg
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Products Corp. · LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
Cleared on Jun 21, 1996 as substantially equivalent to K822883 (M.A. Bioproducts, 1983) after a 494-day review. Its family tree reaches back 1 generation to 1983.
- Decided
- Jun 21, 1996
- Review
- 494 days
- Class
- Class II
- Product code
- LGC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K822883 (1983). No later device cites it as a predicate yet.
- Root · 1 generation backK822883 Herpelisa KitM.A. Bioproducts · 1983
- This deviceK950670 Immulite Herpes I and II IggDiagnostic Products Corp. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K822883 | Herpelisa Kit | M.A. Bioproducts | 1983 | — |
| 0 (this device) | K950670 | Immulite Herpes I and II Igg | Diagnostic Products Corp. | 1996 | — |
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 |
|---|---|---|---|
| * | K822883 | Herpelisa KitSummary page 1…c Products Corporation. (Manufacturing under a Quality System - ISO 9001/EN29001/BS 5750/part 1) EURO/DPC: DPC: Not Applicable 20617183 BioWhittaker HSV ELISA II IgG (K822883) IMMULITE Herpes I & II IgG is a clinical device for use with the IMMULITE Automated Immunoassay Analyzer IMMULITE Herpes I & I… | 1983 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no 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?
IMMULITE Herpes I & II IgG is designed for the qualitative detection of IgG antibodies to herpes simplex virus (HSV) type I & II in human serum. It is intended strictly for in vitro diagnostic use as an aid in the determination of serological status to HSV I & II.
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/K950670 · printed Nov 6, 2026
Cite this page
510(k) Report. “K950670: Immulite Herpes I and II Igg.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950670
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026