510(k) Report

510(k) · Cleared

Recalled · Class II · 2018

Staclot LA Test Kit

K923731510(k) TraditionalCleared Dec 23, 1992149-day reviewClass II21 CFR 864.7925Recalls 3

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

American Bioproducts Co. · GFO Activated Partial Thromboplastin

Cleared on Dec 23, 1992 after a 149-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it. It has been recalled 3 times.

Decided
Dec 23, 1992
Review
149 days
Class
Class II
Product code
GFO
Recalls
3
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2020: 1 descendant cleared1990200020102020
  1. This deviceK923731 Staclot LA Test KitAmerican Bioproducts Co. · 1992
  2. Descendant · cites it directly · 0 of its ownK193556 Cryocheck Hex LAPrecision Biologic · 2020

Most influential descendants

Showing 1 of 1 · See all
  • K193556Cryocheck Hex LAPrecision Biologic · 2020 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K923731Staclot LA Test KitAmerican Bioproducts Co.1992—
+1K193556Cryocheck Hex LAPrecision Biologic2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
FIG. 1 — Lineage of K923731, 1992–2020Source: 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), 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. #1 K253957 HemosIL Silica Clotting Timescore 11.5 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K193556Cryocheck Hex LAPrecision Biologic20200

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 14, 2018Class IIZ-0611-2019Nonconforming Material/ComponentThere have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds.
Nov 14, 2018Class IIZ-0610-2019Nonconforming Material/ComponentThere have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds.
Jul 18, 2006Not classifiedZ-1441-06OtherDecrease in sensitivity ; This could result in a false negative result for patients with weak to moderate lupus anticoagulants.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K193556 (Precision Biologic, 2020) has gone furthest, with 0 descendants of its own.

How does its category compare?

All GFO devices

GFO Activated Partial Thromboplastin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GFO

1in 2020

2016: 12020: 12026 (partial year): 1
2007high 1 (2016) · low 0 (2007)2026

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

2013: 12018: 22025: 1
2007high 2 (2018) · low 0 (2007)2026

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

Adverse event reports per year · GFO

14in 2025

2011: 72013: 32014: 22015: 22016: 32017: 192018: 42019: 12021: 112023: 32024: 22025: 14
2007high 19 (2017) · low 0 (2007)2025

MAUDE reports naming product code GFO, 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
20090—00
20100—00
20110—07
20120—00
20130—13
20140—02
20150—02
20161—03
20170—019
20180—24
20190—01
20201—00
20210—011
20220—00
20230—03
20240—02
20250—114
20261—0—

More from American Bioproducts Co.

79 FDA decisions under this applicant name. See the company

  • K983460Star Automated Multi-Parametric AnalyzerAmerican Bioproducts Co. · 19981 recall
  • K971519Asserachrom Tpa Test KitAmerican Bioproducts Co. · 1997
  • K964716Sta Liatest Control [N]+[P] KitAmerican Bioproducts Co. · 1997
  • K964728Sta-Liatest D-DI Test KitAmerican Bioproducts Co. · 19971 recall
  • K964718Sta D-DI Calibrator KitAmerican Bioproducts Co. · 1997

Recent decisions in GFO

The GFO category page

  • K253957HemosIL Silica Clotting TimeInstrumentation Laboratory (IL) Co. · 2026
  • K193556Cryocheck Hex LAPrecision Biologic · 2020
  • K160445HemosIL Silica Clotting TimeInstrumentation Laboratory CO · 2016
  • K053111Sta-Cephascreen KitDiagnostica Stago, Inc. · 2006
  • K060688Hemosil SynthasilInstrumentation Laboratory CO · 20061 recall

https://510kreport.com/device/K923731 · printed Nov 6, 2026

Cite this page

510(k) Report. “K923731: Staclot LA Test Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K923731

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026