Cleared Traditional

K852484 - PLASTINEX

K852484 is the FDA 510(k) clearance for PLASTINEX by Bio/Data Corp.. It is a Class 2 Hematology device (product code GJS) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K852484 · Bio/Data Corp. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1985
Decision
62d
Days
Class 2
Risk

K852484 is an FDA 510(k) clearance for the PLASTINEX. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Bio/Data Corp. (Hatboro, US). The FDA issued a Cleared decision on August 12, 1985 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7750 - 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: 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 Bio/Data Corp. devices

Submission Details

510(k) Number K852484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1985
Decision Date August 12, 1985
Days to Decision 62 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
51d faster than avg
Panel avg: 113d · This submission: 62d
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 94
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K852484.
THROMBOPLASTIN.FS
K864272 · American Dade · Nov 1986
THROMBOPLASTIN.C
K864273 · American Dade · Nov 1986
THROMBOPLASTIN.R
K864274 · American Dade · Nov 1986
ACA PROTHROMBIN TIME ANALYTICAL TEST PACK
K851125 · E.I. Dupont DE Nemours & Co., Inc. · May 1985
ORTHO BRAIN THROMBOPLASTIN DILUENT
K843535 · Ortho Diagnostic Systems, Inc. · Dec 1984
LIQUID THROMBOPLASTIN REAGENT
K830331 · Helena Laboratories · Apr 1983