Cleared Traditional

K883689 - ORTHO OWREN'S BUFFER

K883689 is the FDA 510(k) clearance for ORTHO OWREN'S BUFFER by Ortho Diagnostic Systems, Inc.. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K883689 · Ortho Diagnostic Systems, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1988
Decision
64d
Days
Class 2
Risk

K883689 is an FDA 510(k) clearance for the ORTHO OWREN'S BUFFER. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Ortho Diagnostic Systems, Inc. (Raritan, US). The FDA issued a Cleared decision on November 1, 1988 after a review of 64 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 Ortho Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K883689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1988
Decision Date November 01, 1988
Days to Decision 64 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
49d faster than avg
Panel avg: 113d · This submission: 64d
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 116
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K883689.
COLLEGE OF AMER PATH. REFER. PREP. FOR FIBRINOGEN
K900377 · Baxter Healthcare Corp · Mar 1990
PLATELET AGGREGATION PROFILER MODEL PAP-4C
K893650 · Bio/Data Corp. · Jun 1989
COAG-A-MATE XC/XC PLUS VERSION D.00 SOFTWARE
K885076 · Organon Teknika Corp. · Dec 1988
KD 0.1 M SODIUM CITRATE SOLUTION
K883635 · King Diagnostics, Inc. · Oct 1988
KD 0.02 M CALCIUM CHLORIDE SOLUTION
K883637 · King Diagnostics, Inc. · Oct 1988
KD ONE-STAGE PROTHROMBIN TIME TEST
K883640 · King Diagnostics, Inc. · Oct 1988