510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Actin FSL Activated PTT Reagent

K863594510(k) TraditionalCleared Oct 17, 198632-day reviewClass II21 CFR 864.7925Recalls 2

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

American Dade · GGW Test, Time, Partial Thromboplastin

Cleared on Oct 17, 1986 after a 32-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled 2 times.

Decided
Oct 17, 1986
Review
32 days
Class
Class II
Product code
GGW
Recalls
2
Predicates
0

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

Descendants, by year cleared 2004: 1 descendant cleared1990200020102020
  1. This deviceK863594 Actin FSL Activated PTT ReagentAmerican Dade · 1986
  2. Descendant · cites it directly · 0 of its ownK033471 Phospholin ES and Calcium ChlorideR2 Diagnostics, Inc. · 2004

Most influential descendants

Showing 1 of 1 · See all
  • K033471Phospholin ES and Calcium ChlorideR2 Diagnostics, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K863594Actin FSL Activated PTT ReagentAmerican Dade1986—
+1K033471Phospholin ES and Calcium ChlorideR2 Diagnostics, Inc.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
FIG. 1 — Lineage of K863594, 1986–2004Source: 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 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?

FDA has not posted a summary or statement for it, 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
K033471Phospholin ES and Calcium ChlorideR2 Diagnostics, Inc.20040

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

Recalls of this device

DateClassRecallRoot causeReason
Mar 11, 2013Class IIZ-1073-2013Unknown/Undetermined by firmSiemens has observed that the listed lot numbers show an increase in Heparin sensitivity over the shelf life which is demonstrated by testing with Dade(R) Citrol(R) Heparin Control, low and high.
Dec 19, 2011Not classifiedZ-1043-2012Unknown/Undetermined by firmThe listed lots of Dade(R) Actin(R) FSL Reagent show an increase in Heparin sensitivity over the shelf life which is demonstrated by testing with Dade(R) Citrol(R) Heparin Control, low and high.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K033471 (R2 Diagnostics, Inc., 2004) has gone furthest, with 0 descendants of its own.

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—

More from American Dade

149 FDA decisions under this applicant name. See the company

  • K873051Stratus (R) HFSH Fluorometric Enzyme ImmunoassayAmerican Dade · 1987
  • K873171Stratus (R) CK-MB Fluorometric Enzyme ImmunoassayAmerican Dade · 1987
  • K873052Stratus (R) HLH Fluorometric Enzyme ImmunoassayAmerican Dade · 1987
  • K872789Paramax Urine/CSF CalibratorAmerican Dade · 1987
  • K872195Data-FI Dimertest Latex AssayAmerican Dade · 1987

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
  • K060284Cryocheck Clot ApcrPrecision Biologic, Inc. · 2006
  • K042762Pefakit Apc-R Factor V LeidenPentapharm, Ltd. · 2004

https://510kreport.com/device/K863594 · printed Nov 5, 2026

Cite this page

510(k) Report. “K863594: Actin FSL Activated PTT Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K863594

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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