510(k) Report

510(k) · Cleared

Cleared

IL Test Aptt-SP

K973306510(k) TraditionalCleared Nov 4, 199762-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

Instrumentation Laboratory CO · GFO Activated Partial Thromboplastin

Cleared on Nov 4, 1997 as substantially equivalent to K881367 (Instrumentation Laboratory CO, 1988) and 4 other predicates after a 62-day review. Its family tree reaches back 1 generation to 1987.

Decided
Nov 4, 1997
Review
62 days
Class
Class II
Product code
GFO
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K871973 (1987). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1996: 1 other ancestor1995: 1 other ancestor1993: 1 other ancestor1988: 1 other ancestorK871973 · IL Monarch 1000 Clinical Chemistry Analytical Sys. · Instrumentation Laboratory CO · 19871986198819901992199419961998
Other ancestors, by generation 1 generation back: 4 other ancestors K871973 · IL Monarch 1000 Clinical Chemistry Analytical Sys. · Instrumentation Laboratory CO · 19870
  1. Root · 1 generation backK871973 IL Monarch 1000 Clinical Chemistry Analytical Sys.Instrumentation Laboratory CO · 1987
  2. This deviceK973306 IL Test Aptt-SPInstrumentation Laboratory CO · 1997
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K871973IL Monarch 1000 Clinical Chemistry Analytical Sys.Instrumentation Laboratory CO1987—
0 (this device)K973306IL Test Aptt-SPInstrumentation Laboratory CO1997—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199310
199510
199610
FIG. 1 — Lineage of K973306, 1987–1997Source: 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 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 11.6 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

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
*K881367Acl Systems 100, 200, 300 and 300+ Coagulation Sys
Summary page 1
…ssification name(s): 864.7925 Partial Thromboplastin Time Tests Class II 81 GFO Activated Partial Thromboplastin Identification of predicate device(s): IL Test™ APTT-C K881367 for ACL 100, 200, 300 & 300+ Coagulation Analyzers K871973 for ACL 1000, 2000, 3000 & 3000+ Coagulation Analyzers K924098 for MCL…
Instrumentation Laboratory CO1988—
*K871973IL Monarch 1000 Clinical Chemistry Analytical Sys.
Summary page 1
…ests Class II 81 GFO Activated Partial Thromboplastin Identification of predicate device(s): IL Test™ APTT-C K881367 for ACL 100, 200, 300 & 300+ Coagulation Analyzers K871973 for ACL 1000, 2000, 3000 & 3000+ Coagulation Analyzers K924098 for MCL-2 Coagulation Analyzer K951891 for ACL Futura K961991 for…
Instrumentation Laboratory CO1987—
*K924098IL MCL-2 Coagulation Analyzer
Summary page 1
…cation of predicate device(s): IL Test™ APTT-C K881367 for ACL 100, 200, 300 & 300+ Coagulation Analyzers K871973 for ACL 1000, 2000, 3000 & 3000+ Coagulation Analyzers K924098 for MCL-2 Coagulation Analyzer K951891 for ACL Futura K961991 for ACL 6000 Coagulation Analyzer Description of the device/intend…
Instrumentation Laboratory CO1993—
*K951891Acl Futura Coagulation System
Summary page 1
…APTT-C K881367 for ACL 100, 200, 300 & 300+ Coagulation Analyzers K871973 for ACL 1000, 2000, 3000 & 3000+ Coagulation Analyzers K924098 for MCL-2 Coagulation Analyzer K951891 for ACL Futura K961991 for ACL 6000 Coagulation Analyzer Description of the device/intended use(s): IL Test™ APTT-SP is intende…
Instrumentation Laboratory CO19952
*K961991Acl 6000 System (Acl 6000)
Summary page 1
…L 100, 200, 300 & 300+ Coagulation Analyzers K871973 for ACL 1000, 2000, 3000 & 3000+ Coagulation Analyzers K924098 for MCL-2 Coagulation Analyzer K951891 for ACL Futura K961991 for ACL 6000 Coagulation Analyzer Description of the device/intended use(s): IL Test™ APTT-SP is intended for the in vitro diag…
Instrumentation Laboratory CO1996—

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?

  • 1 of the 5 ancestors has a recall of any class.

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—

What is it indicated for?

IL Test™ APTT-SP is intended for the in vitro diagnostic determination of Activated Partial Thromboplastin Time (APTT) in citrated plasma on IL Coagulation Systems as a general screening procedure for the evaluation of the intrinsic coagulation pathway and to monitor patients receiving heparin anticoagulant therapy.

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

More from Instrumentation Laboratory CO

321 FDA decisions under this applicant name. See the company

  • K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMInstrumentation Laboratory CO · 2023
  • K223187HemosIL Liquid Anti-XaInstrumentation Laboratory CO · 2023
  • K223090GEM Premier ChemSTATInstrumentation Laboratory CO · 2023
  • K223402HemosIL von Willebrand Factor AntigenInstrumentation Laboratory CO · 2022
  • K213464HemosIL Liquid Anti-XaInstrumentation Laboratory CO · 20222 recalls

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/K973306 · printed Nov 5, 2026

Cite this page

510(k) Report. “K973306: IL Test Aptt-SP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973306

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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