Cleared Traditional

VERIFY REFERENCE PLASMA AND MDA VERIFY REF. PLASMA (K930849) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K930849 · Organon Teknika Corp. · Hematology device
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Apr 1993
Decision
61d
Days
Class 2
Risk

K930849 is an FDA 510(k) clearance for the VERIFY REFERENCE PLASMA AND MDA VERIFY REF. PLASMA. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on April 20, 1993 after a review of 61 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 Organon Teknika Corp. devices

Submission Details

510(k) Number K930849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1993
Decision Date April 20, 1993
Days to Decision 61 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
52d faster than avg
Panel avg: 113d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 72
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K930849.
BEHRING FIBRINTIMER A
K926551 · Behring Diagnostics, Inc. · Apr 1995
ACT CONTROL SET
K940840 · Sigma Diagnostics, Inc. · Jul 1994
BOEHRINGER MANNHEIM COAGUCHEK SYSTEM
K930454 · Boehringer Mannheim Corp. · Aug 1993
OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376
K926222 · Helena Laboratories · Feb 1993
CALCIUM CHLORIDE/DIETHYLBARB ACETATE BUFF SOLUTION
K924509 · Behring Diagnostics, Inc. · Dec 1992
MULTI-CHANNEL DISCRETE ANALYZER (MDA-180)
K924453 · Organon Teknika Corp. · Dec 1992