Cleared Traditional

K931117 - ASSESS(TM) LOW ABNORMAL CONTROL

K931117 is the FDA 510(k) clearance for ASSESS(TM) LOW ABNORMAL CONTROL by Instrumentation Laboratory CO. It is a Class 2 Hematology device (product code GJS) cleared through the Traditional 510(k) pathway after a 391-day FDA review.

K931117 · Instrumentation Laboratory CO · Hematology device
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Mar 1994
Decision
391d
Days
Class 2
Risk

K931117 is an FDA 510(k) clearance for the ASSESS(TM) LOW ABNORMAL CONTROL. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on March 30, 1994 after a review of 391 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7750 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Instrumentation Laboratory CO devices

Submission Details

510(k) Number K931117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1993
Decision Date March 30, 1994
Days to Decision 391 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
278d slower than avg
Panel avg: 113d · This submission: 391d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GJS Test, Time, Prothrombin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7750
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 - GJS Test, Time, Prothrombin

All 76
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K931117.
ORTHO RECOMBIPLASTIN II W/ORTHO RECOMBIPLASTIN II DILUENT
K935748 · Ortho Diagnostic Systems, Inc. · Apr 1995
DADE INNOVIN II
K935702 · Baxter Diagnostics, Inc. · Nov 1994
HELENA THROMBOPLASTIN-MI REAGENT
K940310 · Helena Laboratories · Apr 1994
ASSESS(TM) HIGH ABNORMAL CONTROL
K931118 · Instrumentation Laboratory CO · Mar 1994
IL TEST (TM) PT-FIBRINOGEN HS PLUS
K933252 · Instrumentation Laboratory CO · Oct 1993
THROMBOPLATIN-M WITH CALCIUM
K930212 · Sigma Diagnostics, Inc. · May 1993