510(k) · Cleared
ClearedCryo-Check PNP Platelet Lysate, Model PNP-10
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precision Biologicals, Inc. · GGW Test, Time, Partial Thromboplastin
Cleared on Jan 13, 1999 as substantially equivalent to K873382 (Bio/Data Corp., 1987) after a 212-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- Jan 13, 1999
- Review
- 212 days
- Class
- Class II
- Product code
- GGW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K873382 (1987). No later device cites it as a predicate yet.
- Root · 1 generation backK873382 Platelet Extract ReagentBio/Data Corp. · 1987
- This deviceK982062 Cryo-Check PNP Platelet Lysate, Model PNP-10Precision Biologicals, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K873382 | Platelet Extract Reagent | Bio/Data Corp. | 1987 | — |
| 0 (this device) | K982062 | Cryo-Check PNP Platelet Lysate, Model PNP-10 | Precision Biologicals, Inc. | 1999 | — |
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 GGW? 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 GGW device
- #1 K260551 HemosIL Factor V Leiden (APC Resistance V)score 11.3 · 2 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 |
|---|---|---|---|
| * | K873382 | Platelet Extract ReagentSummary page 2…n Procedure (PNP). The PNP is useful in detecting the presence of lupus anticoagulants in human plasma. 5. Substantially Equivalent Device a) b) c) d) 510(k) number: K873382 Trade Name: Platelet Extract Reagent Manufacturer: BIO/DATA Corporation Substantial Equivalence Comparison Cryov'Check™ PNP Pl… | 1987 |
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.
How does its category compare?
All GGW devicesGGW Test, Time, Partial Thromboplastin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GGW
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · GGW
Too few GGW 510(k)s in any year since 2007 to give a median.
Recalls per year · GGW
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GGW
11in 2025
MAUDE reports naming product code GGW, 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 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 1 | 0 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 15 |
| 2018 | 0 | — | 0 | 18 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 11 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Cryov Check™ PNP Platelet Lysate is intended for use in the Platelet Neutralization
Procedure (PNP) which is useful in detecting the presence of lupus anticoagulants (LA)
in human plasma.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982062 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982062: Cryo-Check PNP Platelet Lysate, Model PNP-10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982062
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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