510(k) Report

510(k) · Cleared

Cleared

Sta Liatest Control [N]+[P] Kit

K964716510(k) TraditionalCleared Jun 26, 1997213-day reviewClass II21 CFR 864.5425

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

American Bioproducts Co. · GGN Plasma, Coagulation Control

Cleared on Jun 26, 1997 after a 213-day review. The FDA summary names no predicate by number. 7 later devices descend from it.

Decided
Jun 26, 1997
Review
213 days
Class
Class II
Product code
GGN
Recalls
None
Predicates
0

7 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2003: 2 descendants cleared2005: 1 descendant cleared2011: 1 descendant cleared2016: 1 descendant cleared2017: 2 descendants cleared1995200020052010201520202025
  1. This deviceK964716 Sta Liatest Control [N]+[P] KitAmerican Bioproducts Co. · 1997
  2. Descendant · cites it directly · 6 of its ownK030182 Liquichek D-Dimer Control, Model 356, 357Bio-Rad · 2003
  3. Descendant · 2 generations on · 5 of its ownK032017 Liquichek D-Dimer Control Level 1, 2 and 3Bio-Rad · 2003
  4. Descendant · 3 generations on · 4 of its ownK050799 Triage (R) D-Dimer Calibration Verification Controls; Triage (R)…Biosite Incorporated · 2005
  5. Descendant · 4 generations on · 3 of its ownK100716 Audit Microcv D-Dimer Linearity Set, Model K717M-5Aalto Scientific, Ltd. · 2011
  6. Descendant · 5 generations on · 2 of its ownK152961 VALIDATE D-Dimer Calibration Verification/Linearity Test KitMaine Standards Company, LLC · 2016

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2003: 22005: 12011: 12016: 12017: 2
2003high 2 (2003) · low 0 (2004)2026

Most influential descendants

Showing 5 of 7 · See all
  • K030182Liquichek D-Dimer Control, Model 356, 357Bio-Rad · 2003 · cites it directly6descendants
  • K032017Liquichek D-Dimer Control Level 1, 2 and 3Bio-Rad · 2003 · 2 generations on5descendants
  • K050799Triage (R) D-Dimer Calibration Verification Controls; Triage (R) D-Dimer ControlsBiosite Incorporated · 2005 · 3 generations on4descendants
  • K100716Audit Microcv D-Dimer Linearity Set, Model K717M-5Aalto Scientific, Ltd. · 2011 · 4 generations on3descendants
  • K152961VALIDATE D-Dimer Calibration Verification/Linearity Test KitMaine Standards Company, LLC · 2016 · 5 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K964716Sta Liatest Control [N]+[P] KitAmerican Bioproducts Co.1997—
+1K030182Liquichek D-Dimer Control, Model 356, 357Bio-Rad2003—
+2K032017Liquichek D-Dimer Control Level 1, 2 and 3Bio-Rad2003—
+3K050799Triage (R) D-Dimer Calibration Verification Controls; Triage (R) D-Dimer…Biosite Incorporated2005—
+4K100716Audit Microcv D-Dimer Linearity Set, Model K717M-5Aalto Scientific, Ltd.2011—
+5K152961VALIDATE D-Dimer Calibration Verification/Linearity Test KitMaine Standards Company, LLC2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200320
200510
201110
201610
201720
FIG. 1 — Lineage of K964716, 1997–2017Source: 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 GGN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K030182Liquichek D-Dimer Control, Model 356, 357Bio-Rad20036

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?

  • Of its descendants, K030182 (Bio-Rad, 2003) has gone furthest, with 6 descendants of its own.

How does its category compare?

All GGN devices

GGN Plasma, Coagulation Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GGN

4in 2017

2007: 32008: 12009: 22010: 32011: 22012: 12013: 32014: 22016: 22017: 4
2007high 4 (2017) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GGN

96in 2017

2007: 47 days median2010: 23 days median2013: 441 days median2017: 96 days median
2007high 441 (2013) · low 23 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GGN

1in 2019

2010: 42011: 12013: 32019: 12026 (partial year): 2
2007high 4 (2010) · low 0 (2007)2026

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

Adverse event reports per year · GGN

4in 2018

2009: 372010: 172011: 302012: 102013: 92014: 52015: 102016: 92017: 112018: 4
2007high 37 (2009) · low 0 (2007)2025

MAUDE reports naming product code GGN, 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
200734700
20081—00
20092—037
2010323417
20112—130
20121—010
2013344139
20142—05
20150—010
20162—09
2017496011
20180—04
20190—10
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—2—

What is it indicated for?

The STA® Liatest® Control [N]+[P] kit is intended for use as control plasmas (Normal and Abnormal levels) for von Willebrand Factor (vWF) and D-dimer antigen assays by the immuno-turbidimetric method performed on STA® analyzers (Diagnostica Stago, France: STA® full-size model, K942117; STA® Compact model, K961579).

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

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
  • K964728Sta-Liatest D-DI Test KitAmerican Bioproducts Co. · 19971 recall
  • K964718Sta D-DI Calibrator KitAmerican Bioproducts Co. · 1997
  • K962675Sta - Liatest VWF Test KitAmerican Bioproducts Co. · 19961 recall

Recent decisions in GGN

The GGN category page

  • K170864VALIDATE D-Dimer Calibration Verification / Linearity Test KitMaine Standards Company, LLC · 2017
  • K163498VALIDATE Heparin Calibration Verification/Linearity Test KitMaine Standards Company, LLC · 2017
  • K161316George King Coumadin PlasmaGeorge King Bio-Medical, Inc. · 2017
  • K162705VALIDATE® D-Dimer Calibration Verification/ Linearity Test KitMaine Standards Company, LLC · 2017
  • K152961VALIDATE D-Dimer Calibration Verification/Linearity Test KitMaine Standards Company, LLC · 2016

https://510kreport.com/device/K964716 · printed Nov 5, 2026

Cite this page

510(k) Report. “K964716: Sta Liatest Control [N]+[P] Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964716

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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