Cleared Traditional

K780285 - SOLUBLE COLLAGEN

K780285 is the FDA 510(k) clearance for SOLUBLE COLLAGEN by General Diagnostics. It is a Class 2 Hematology device (product code JOZ) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K780285 · General Diagnostics · Hematology device
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Mar 1978
Decision
37d
Days
Class 2
Risk

K780285 is an FDA 510(k) clearance for the SOLUBLE COLLAGEN. Classified as System, Automated Platelet Aggregation (product code JOZ), Class II - Special Controls.

Submitted by General Diagnostics (Mchenry, US). The FDA issued a Cleared decision on March 30, 1978 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5700 - 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.

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Submission Details

510(k) Number K780285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1978
Decision Date March 30, 1978
Days to Decision 37 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
76d faster than avg
Panel avg: 113d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOZ System, Automated Platelet Aggregation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5700
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 - JOZ System, Automated Platelet Aggregation

All 12
Devices cleared under the same product code (JOZ) and FDA review panel - the closest regulatory comparables to K780285.
HELENA RISTOCETIN
K800432 · Helena Laboratories · Mar 1980
ELVI 840 AGGREGOMETER
K791577 · Volu Sol Medical Industries · Sep 1979
BETA/PAK
K790769 · Bio/Data Corp. · May 1979
PLATELET AGGREGATING REAGENTS
K780047 · Dade, Baxter Travenol Diagnostics, Inc. · Mar 1978
AGGRECETIN
K760893 · Bio/Data Corp. · Jan 1977