510(k) Report

510(k) · Cleared

Cleared

Cryocheck Clot Apcr

K060284510(k) TraditionalCleared May 10, 200696-day reviewClass II21 CFR 864.7925

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Precision Biologic, Inc. · GGW Test, Time, Partial Thromboplastin

Cleared on May 10, 2006 as substantially equivalent to K992456 (Gradipore, Ltd., 1999) after a 96-day review. Its family tree reaches back 1 generation to 1999.

Decided
May 10, 2006
Review
96 days
Class
Class II
Product code
GGW
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K992456 (1999). No later device cites it as a predicate yet.

K992456 · Gradileiden V Test · Gradipore, Ltd. · 19991996199820002002200420062008
K992456 · Gradileiden V Test · Gradipore, Ltd. · 19990
  1. Root · 1 generation backK992456 Gradileiden V TestGradipore, Ltd. · 1999
  2. This deviceK060284 Cryocheck Clot ApcrPrecision Biologic, Inc. · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K992456Gradileiden V TestGradipore, Ltd.1999—
0 (this device)K060284Cryocheck Clot ApcrPrecision Biologic, Inc.2006—
FIG. 1 — Lineage of K060284, 1999–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K260551 HemosIL Factor V Leiden (APC Resistance V)score 11.3 · 2 generations · no Class I recall
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K992456Gradileiden V Test
Summary page 1
…lly marketed device to which the submitter claims substantial equivalence Predicate Device Name: GradiLeiden V 510(k) number: K992456 Regulation Number: 864.7925 Regulatory Class: ]!…
Gradipore, Ltd.1999—

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 devices

GGW Test, Time, Partial Thromboplastin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GGW

1in 2010

2009: 12010: 12026 (partial year): 1
2007high 1 (2009) · low 0 (2007)2026

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

2011: 1
2007high 1 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GGW

11in 2025

2012: 42013: 22014: 22016: 72017: 152018: 182019: 32020: 42021: 42022: 12024: 52025: 11
2007high 18 (2018) · low 0 (2007)2025

MAUDE reports naming product code GGW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20091—00
20101—00
20110—10
20120—04
20130—02
20140—02
20150—00
20160—07
20170—015
20180—018
20190—03
20200—04
20210—04
20220—01
20230—00
20240—05
20250—011
20261—0—

What is it indicated for?

CRYocheck Clot APCR is a clotting assay intended to screen for resistance to activated protein C in citrated human plasma from individuals with the factor VLeiden mutation.

Indications for use as stated in the FDA summary.

More from Precision Biologic, Inc.

7 FDA decisions under this applicant name. See the company

  • K251440CRYOcheck Chromogenic Factor VIIIPrecision Biologic, Inc. · 2025
  • K222831CRYOcheck Factor VIII Deficient Plasma with VWFPrecision Biologic, Inc. · 2023
  • K214002CRYOcheck Chromogenic Factor IXPrecision Biologic, Inc. · 2022
  • K183440CRYOcheck FVIII Inhibitor KitPrecision Biologic, Inc. · 2019
  • K043571Cryocheck Clot SPrecision Biologic, Inc. · 2005

Recent decisions in GGW

The GGW category page

  • K260551HemosIL Factor V Leiden (APC Resistance V)Instrumentation Laboratory (IL) Co. · 2026
  • K090105Lupotek KCTR2 Diagnostics, Inc. · 2010
  • K083729Hemoclot Quanti- V-L, Factor V-L Calibrator, Biophen V-L Cal (Undiluted), Biophen Act. PC-R Control Plasma…Aniara Diagnostica, LLC · 2009
  • K042762Pefakit Apc-R Factor V LeidenPentapharm, Ltd. · 2004
  • K033471Phospholin ES and Calcium ChlorideR2 Diagnostics, Inc. · 2004

https://510kreport.com/device/K060284 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060284: Cryocheck Clot Apcr.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060284

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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