510(k) · Cleared
ClearedCoatest SP Fviii
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 2, 2004 as substantially equivalent to K833892 (Kabivitrum, Inc., 1984) after a 71-day review. Its family tree reaches back 1 generation to 1984. 2 later devices descend from it.
- Decided
- Dec 2, 2004
- Review
- 71 days
- Class
- Class II
- Product code
- GGP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K833892 (1984). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK833892 Coatest Factor ViiiKabivitrum, Inc. · 1984
- This deviceK042576 Coatest SP FviiiInstrumentation Laboratory CO · 2004
- Descendant · cites it directly · 1 of its ownK193204 Cryocheck Chromogenic Factor VIIIPrecision Biologic · 2020
- Descendant · 2 generations on · 0 of its ownK251440 CRYOcheck Chromogenic Factor VIIIPrecision Biologic, Inc. · 2025
Most influential descendants
Showing 2 of 2 · See allView 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) | K042576 | Coatest SP Fviii | Instrumentation Laboratory CO | 2004 | — |
| +1 | K193204 | Cryocheck Chromogenic Factor VIII | Precision Biologic | 2020 | — |
| +2 | K251440 | CRYOcheck Chromogenic Factor VIII | Precision Biologic, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K833892 | Coatest Factor ViiiSummary page 1…n Name: 864.7290 Factor Deficiency Test Class II 81GGP Test, Qualitative and Quantitative Factor Deficiency Identification of predicate device: K833892 Coatest Factor VIII Description of the device: Coatest SP FVIIH is intended for the photometric determination of factor… | 1984 |
| † | K981038 | Coamatic Factor Viii | 1998 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193204 | Cryocheck Chromogenic Factor VIII | 2020 | 1 |
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?
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 SP FVIII is intended for the photometric determination of factor VIII activity in citrated plasma, such as when identifying factor VIII deficiency or monitoring patients on replacement therapy, as well as for potency estimation of FVIII concentrates.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042576 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042576: Coatest SP Fviii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042576
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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