Cleared Traditional

K864271 - IL TEST 84673-30 CHROMOGENICS CONTROL PLASMA

K864271 is an FDA 510(k) clearance for IL TEST 84673-30 CHROMOGENICS CONTROL P..., manufactured by Instrumentation Laboratory CO. The device is a Class 2 Hematology device with product code JPA cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K864271 · Instrumentation Laboratory CO · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1986
Decision
27d
Days
Class 2
Risk

K864271 is an FDA 510(k) clearance for the IL TEST 84673-30 CHROMOGENICS CONTROL PLASMA. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on November 25, 1986 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - 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 - K864271

510(k) Number K864271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1986
Decision Date November 25, 1986
Days to Decision 27 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 113d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JPA Device Classification - Class 2, Special Controls

Product Code JPA System, Multipurpose For In Vitro Coagulation Studies
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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 - JPA System, Multipurpose For In Vitro Coagulation Studies

All 151
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K864271.
COAG-A-MATE(R) XC
K870960 · Organon Teknika Corp. · Mar 1987
ELECTRA(R) 700 AUTOMATIC COAGULATION TIMER
K864532 · Medical Laboratory Automation Systems, Inc. · Feb 1987
ELECTRA(R) 800 AUTOMATIC COAGULATION TIMER
K864534 · Medical Laboratory Automation Systems, Inc. · Feb 1987
KOAGULAB* M COAGULATION SYSTEM
K862537 · Ortho Diagnostic Systems, Inc. · Jul 1986
COASCREENER/DIASCREENERBLOOD PLASMA TIMING INST.
K854938 · Diatech, Inc. · Mar 1986
MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP
K860342 · Bio/Data Corp. · Mar 1986