510(k) · Cleared
ClearedModification to Coatest Factor Viii
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · GGP Test, Qualitative And Quantitative Factor Deficiency
Cleared on Dec 15, 2003 as substantially equivalent to K833892 (Kabivitrum, Inc., 1984) after a 26-day review. Its family tree reaches back 1 generation to 1984.
- Decided
- Dec 15, 2003
- Review
- 26 days
- Class
- Class II
- Product code
- GGP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K833892 (1984). No later device cites it as a predicate yet.
- Root · 1 generation backK833892 Coatest Factor ViiiKabivitrum, Inc. · 1984
- This deviceK033631 Modification to Coatest Factor ViiiInstrumentation Laboratory CO · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K833892 | Coatest Factor Viii | Kabivitrum, Inc. | 1984 | — |
| 0 (this device) | K033631 | Modification to Coatest Factor Viii | Instrumentation Laboratory CO | 2003 | — |
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 |
|---|---|---|---|
| * | K833892 | Coatest Factor ViiiSummary page 1…on Name: 864.7290 Factor Deficiency Test Class II 8IGGP Test, Qualitative and Quantitative Factor Deficiency Identification of predicate device: K833892 Coatest Factor VIIi Description of the modified device: Coatest Factor VIII (K833892) was modified to substitute the natura… | 1984 |
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.
- 2 other devices also cite its predicate K833892.
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.
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?
Coatest Factor VIE was modified to substitute the natural porcine phospholipids in the Phospholipid reagent with synthetic phospholipids. This modification does not alter the fundamental scientific technology of the device or its intended use for the photometric determination of Factor VIff activity in citrated plasma.
For in vitro diagnostic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033631 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033631: Modification to Coatest Factor Viii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033631
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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