Cleared Traditional

K973306 - IL TEST APTT-SP

K973306 is an FDA 510(k) clearance for IL TEST APTT-SP, manufactured by Instrumentation Laboratory CO. The device is a Class 2 Hematology device with product code GFO cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K973306 · Instrumentation Laboratory CO · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1997
Decision
62d
Days
Class 2
Risk

K973306 is an FDA 510(k) clearance for the IL TEST APTT-SP. Classified as Activated Partial Thromboplastin (product code GFO), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Orangeburg, US). The FDA issued a Cleared decision on November 4, 1997 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7925 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Instrumentation Laboratory CO devices

FDA 510(k) Submission Details - K973306

510(k) Number K973306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1997
Decision Date November 04, 1997
Days to Decision 62 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 113d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GFO Device Classification - Class 2, Special Controls

Product Code GFO Activated Partial Thromboplastin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7925
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - GFO Activated Partial Thromboplastin

All 43
Devices cleared under the same product code (GFO) and FDA review panel - the closest regulatory comparables to K973306.
SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094
K992711 · Sigma Diagnostics, Inc. · Dec 1999
SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334
K992712 · Sigma Diagnostics, Inc. · Dec 1999
HEMOCHRON CITRATE APTT
K972831 · International Technidyne Corp. · Nov 1997
SPECKTIN-LA TEST SET
K961892 · Analytical Control Systems, Inc. · Mar 1997
SYNTHAFAX APTT REAGENT
K955638 · Ortho Diagnostic Systems, Inc. · Apr 1996
PATHROMTIN SL
K955450 · Behring Diagnostics, Inc. · Apr 1996