Cleared Traditional

K870354 - IMMUNOADSORBED FACTOR V DEFICIENT PLASM...

K870354 is the FDA 510(k) clearance for IMMUNOADSORBED FACTOR V DEFICIENT PLASM... by American Dade. It is a Class 2 Hematology device (product code GGP) cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K870354 · American Dade · Hematology device
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Feb 1987
Decision
12d
Days
Class 2
Risk

K870354 is an FDA 510(k) clearance for the IMMUNOADSORBED FACTOR V DEFICIENT PLASMA (HUMAN). Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by American Dade (Santa Ana, US). The FDA issued a Cleared decision on February 10, 1987 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7290 - 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 American Dade devices

Submission Details

510(k) Number K870354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1987
Decision Date February 10, 1987
Days to Decision 12 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
101d faster than avg
Panel avg: 113d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGP Test, Qualitative And Quantitative Factor Deficiency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7290
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 - GGP Test, Qualitative And Quantitative Factor Deficiency

All 126
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K870354.
STACHROM PROTEIN C TEST KIT
K871039 · American Bioproducts Co. · May 1987
PROTEIN S CONTROL PLASMA
K870917 · American Bioproducts Co. · Apr 1987
IMMUNOADSORBED FACTOR X DEFICIENT PLASMA (HUMAN)
K870353 · American Dade · Feb 1987
IL TEST 84668-15, FACTOR VIII CONTROL PLASMA
K864480 · Instrumentation Laboratory CO · Jan 1987
COAGULATION INTRINSIC DEFICIENT PLASMAS
K864481 · Instrumentation Laboratory CO · Jan 1987
COAGULATION EXTRINSIC DEFICIENT PLASMAS
K864497 · Instrumentation Laboratory CO · Jan 1987