510(k) · Cleared
ClearedCryocheck Hex LA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precision Biologic · GFO Activated Partial Thromboplastin
Cleared on Oct 23, 2020 as substantially equivalent to K923731 (American Bioproducts Co., 1992) after a 305-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Oct 23, 2020
- Review
- 305 days
- Class
- Class II
- Product code
- GFO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K923731 (1992). No later device cites it as a predicate yet.
- Root · 1 generation backK923731 Staclot LA Test KitAmerican Bioproducts Co. · 1992 · Recalled
- This deviceK193556 Cryocheck Hex LAPrecision Biologic · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923731 | Staclot LA Test Kit | American Bioproducts Co. | 1992 | 3 |
| 0 (this device) | K193556 | Cryocheck Hex LA | Precision Biologic | 2020 | — |
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 GFO? 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 GFO device
- #1 K253957 HemosIL Silica Clotting Timescore 11.6 · 4 generations · no Class I recall
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 |
|---|---|---|---|
| * | K923731 | Staclot LA Test KitSummary page 4…1 CFR 864.7290 Classification Panel Hematology Predicate Device Staclot LA (K923731) Indication for Use/ CRYOcheck Hex LA is for clinical laboratory use as a qualitative test kit Intended Use intend… | 1992 |
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 a recall.
How does its category compare?
All GFO devicesGFO Activated Partial Thromboplastin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · GFO
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · GFO
Too few GFO 510(k)s in any year since 2007 to give a median.
Recalls per year · GFO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GFO
14in 2025
MAUDE reports naming product code GFO, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 7 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 3 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 1 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 19 |
| 2018 | 0 | — | 2 | 4 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 11 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 1 | 14 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Cryocheck Hex LA is for clinical laboratory use as a qualitative test kit intended to aid in the detection of lupus anticoagulants (LA) in 3.2% citrated human plasma by the application of hexagonal phase phospholipids. Cryocheck Hex LA should be used as an integrated test for lupus anticoagulant detection. For in vitro diagnostic use. The performance of this device has not been established in neonate and pediatric patient populations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193556 · printed Nov 5, 2026
Cite this page
510(k) Report. “K193556: Cryocheck Hex LA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K193556
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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