510(k) · Cleared
ClearedIncstar HSV I/II Igg Fast Elisa Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Incstar Corp. · IGC Formalin-Saline
Cleared on Jul 24, 1996 as substantially equivalent to K852782 (Clinical Sciences, Inc., 1986) and 1 other predicate after a 245-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Jul 24, 1996
- Review
- 245 days
- Class
- Class I
- Product code
- IGC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K852782 (1986). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK852782 Hsvi - Igg Elisa-KitClinical Sciences, Inc. · 1986
- This deviceK955362 Incstar HSV I/II Igg Fast Elisa AssayIncstar Corp. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K852782 | Hsvi - Igg Elisa-Kit | Clinical Sciences, Inc. | 1986 | — |
| 0 (this device) | K955362 | Incstar HSV I/II Igg Fast Elisa Assay | Incstar Corp. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
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 IGC? 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? (2)
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 |
|---|---|---|---|
| * | K852782 | Hsvi - Igg Elisa-KitSummary page 3…to the solid phase. SAFETY AND EFFECTIVENESS: The INCSTAR HSV I/ll IgG “fast” ELISA Kit is substantially equivalent (SE) to the Herpes 1 1gG Clin-ELISA kit, 510(k) No. K852782 in combination with the Herpes 2 IgG Clin-ELISA kit, 510(k) No. K852781 which have been cleared by the FDA and are currently in U… | 1986 |
| * | K852781 | HSV2 - Igg Elisa-KitSummary page 3…“fast” ELISA Kit is substantially equivalent (SE) to the Herpes 1 1gG Clin-ELISA kit, 510(k) No. K852782 in combination with the Herpes 2 IgG Clin-ELISA kit, 510(k) No. K852781 which have been cleared by the FDA and are currently in U.S. commercial distribution. In clinical performance studies, 305 serum… | 1986 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All IGC devicesIGC Formalin-Saline: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IGC
FDA has decided no IGC device since 2007.
Median 510(k) review, days · IGC
Too few IGC 510(k)s in any year since 2007 to give a median.
Recalls per year · IGC
No recall names IGC since 2007.
Adverse event reports per year · IGC
No MAUDE report names IGC since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The INCSTAR Herpes Simplex Virus Vil IgG “fast” ELISA kit contains instructions and materials for the qualitative and/or semi-quantitative detection of IgG antibodies to herpes simplex virus type 1 and/or type 2 in human serum by indirect enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the INCSTAR Herpes Simplex Virus /1l 1gG “fast” ELISA test is of value in the determination of immunological response to infection with HSV. The evaluation of paired sera, acute and convalescent, by demonstrating seroconversion or a significant rise in antibody can aid in the diagnosis of primary infection with herpes simplex virus.
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/K955362 · printed Nov 6, 2026
Cite this page
510(k) Report. “K955362: Incstar HSV I/II Igg Fast Elisa Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955362
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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