510(k) · Cleared
ClearedFactor Viii Antibody Screen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genetic Testing Institute · GGP Test, Qualitative And Quantitative Factor Deficiency
Cleared on Nov 20, 2008 as substantially equivalent to K993553 (Genetic Testing Institute, 2000) after a 107-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Nov 20, 2008
- Review
- 107 days
- Class
- Class II
- Product code
- GGP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K993553 (2000). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K183440CRYOcheck FVIII Inhibitor KitPrecision Biologic, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K993553 | Gti-Fviii Inhibitor Assay | Genetic Testing Institute | 2000 | — |
| 0 (this device) | K082205 | Factor Viii Antibody Screen | Genetic Testing Institute | 2008 | — |
| +1 | K183440 | CRYOcheck FVIII Inhibitor Kit | Precision Biologic, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 GGP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GGP device
- #1 K251440 CRYOcheck Chromogenic Factor VIIIscore 10.5 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K993553 | Gti-Fviii Inhibitor AssaySummary page 1…itative Factor Deficiency Product Code: GGP III. Name of predicate device for claiming equivalence GTI Factor VIII Inhibitor Assay (K993 553) IV. Description of Device: The Factor VIII Antibody Screen is an Enzyme Linked Immunosorbent Assay with a colorimetric endpoin… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183440 | CRYOcheck FVIII Inhibitor Kit | 2019 | 0 |
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.
- Of its descendants, K183440 (Precision Biologic, Inc., 2019) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GGP devicesGGP Test, Qualitative And Quantitative Factor Deficiency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · GGP
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GGP
153in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GGP
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GGP
3in 2025
MAUDE reports naming product code GGP, 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 | 3 | 153 | 2 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 2 | 4 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 2 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 1 | 3 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 2 | — | 0 | 4 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Factor VIII Antibody Screen is designed as a solid phase enzyme-linked immunosorbent assay (ELISA) with a colorimetric endpoint. This product is intended to be used as an in vitro diagnostic kit by hemostasis and other laboratories to screen patient samples for the presence of IgG antibodies reactive with human Factor VIII.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082205 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082205: Factor Viii Antibody Screen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082205
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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