Cleared Traditional

K854015 - FS TEST KIT

K854015 is an FDA 510(k) clearance for FS TEST KIT, manufactured by American Bioproducts Co.. The device is a Class 2 Hematology device with product code JBN cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K854015 · American Bioproducts Co. · Hematology device
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Mar 1986
Decision
160d
Days
Class 2
Risk

K854015 is an FDA 510(k) clearance for the FS TEST KIT. Classified as Fibrin Monomer Paracoagulation (product code JBN), Class II - Special Controls.

Submitted by American Bioproducts Co. (Parsippany, US). The FDA issued a Cleared decision on March 6, 1986 after a review of 160 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7300 - 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 - K854015

510(k) Number K854015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1985
Decision Date March 06, 1986
Days to Decision 160 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
47d slower than avg
Panel avg: 113d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JBN Device Classification - Class 2, Special Controls

Product Code JBN Fibrin Monomer Paracoagulation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7300
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.