Cleared Traditional

K854384 - ASSERACHROM FPA KIT

K854384 is an FDA 510(k) clearance for ASSERACHROM FPA KIT, manufactured by American Bioproducts Co.. The device is a Class 2 Hematology device with product code DAN cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K854384 · American Bioproducts Co. · Hematology device
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Feb 1986
Decision
97d
Days
Class 2
Risk

K854384 is an FDA 510(k) clearance for the ASSERACHROM FPA KIT. Classified as Fibrinopeptide A, Antigen, Antiserum, Control (product code DAN), Class II - Special Controls.

Submitted by American Bioproducts Co. (Parsippany, US). The FDA issued a Cleared decision on February 4, 1986 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 866.5350 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all American Bioproducts Co. devices

FDA 510(k) Submission Details - K854384

510(k) Number K854384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1985
Decision Date February 04, 1986
Days to Decision 97 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
16d faster than avg
Panel avg: 113d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DAN Device Classification - Class 2, Special Controls

Product Code DAN Fibrinopeptide A, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5350
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.