510(k) · Cleared
ClearedCRYOcheck Chromogenic Factor VIII
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precision Biologic, Inc. · GGP Test, Qualitative And Quantitative Factor Deficiency
Cleared on Aug 25, 2025 as substantially equivalent to K193204 (Precision Biologic, 2020) after a 108-day review. Its family tree reaches back 3 generations to 1984.
- Decided
- Aug 25, 2025
- Review
- 108 days
- Class
- Class II
- Product code
- GGP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K833892 (1984). No later device cites it as a predicate yet.
- Root · 3 generations backK833892 Coatest Factor ViiiKabivitrum, Inc. · 1984
- 2 generations backK042576 Coatest SP FviiiInstrumentation Laboratory CO · 2004
- 1 generation backK193204 Cryocheck Chromogenic Factor VIIIPrecision Biologic · 2020
- This deviceK251440 CRYOcheck Chromogenic Factor VIIIPrecision Biologic, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K833892 | Coatest Factor Viii | Kabivitrum, Inc. | 1984 | — |
| −2 | K042576 | Coatest SP Fviii | Instrumentation Laboratory CO | 2004 | — |
| −1 | K193204 | Cryocheck Chromogenic Factor VIII | Precision Biologic | 2020 | — |
| 0 (this device) | K251440 | CRYOcheck Chromogenic Factor VIII | Precision Biologic, Inc. | 2025 | — |
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 K230852 HemosIL Chromogenic Factor IXscore 6.8 · 2 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 |
|---|---|---|---|
| * | K193204 | Cryocheck Chromogenic Factor VIIISummary page 5…Changed CRYOcheck Chromogenic Factor VIII Chromogenic Factor VIII 510(k) Number K193204 K251440 Measurand Human Factor VIII activity Same === Page 6… | 2020 |
| † | K160276 | Acl Top (Acl Top 700, Acl Top 700 CTS, Acl Top 700 Las, Acl Top 500 CTS, Acl Top 300 CTS) | 2016 |
| † | K150877 | Acl Top Family 50 Series: Acl Top 350 CTS; Acl Top 550 CTS; Acl Top 750; Acl Top 750… | 2015 |
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?
- The line of descent spans 41 years and passes through 4 companies; a new generation was cleared every 15.6 years on median.
- None of the 3 ancestors has a recall.
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. 2025, 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?
CRYOcheck Chromogenic Factor VIII is for clinical laboratory use in the quantitative determination of factor VIII activity in 3.2 % citrated human plasma. It is intended to be used in identifying factor VIII deficiency and as an aid in the management of hemophilia A in individuals aged 2 years and older. For in vitro diagnostic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251440 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251440: CRYOcheck Chromogenic Factor VIII.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251440
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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