Cleared Traditional

K914040 - PHOSPHOLIPID REAGENT SET

K914040 is the FDA 510(k) clearance for PHOSPHOLIPID REAGENT SET by Sterling Diagnostics, Inc.. It is a Class 1 Chemistry device (product code JNT) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K914040 · Sterling Diagnostics, Inc. · Chemistry device
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Oct 1991
Decision
50d
Days
Class 1
Risk

K914040 is an FDA 510(k) clearance for the PHOSPHOLIPID REAGENT SET. Classified as Chromatographic, Phospholipids (product code JNT), Class I - General Controls.

Submitted by Sterling Diagnostics, Inc. (Sterling Heights, US). The FDA issued a Cleared decision on October 30, 1991 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1575 - the FDA in vitro diagnostics and chemistry 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 Sterling Diagnostics, Inc. devices

Submission Details

510(k) Number K914040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1991
Decision Date October 30, 1991
Days to Decision 50 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 88d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JNT Chromatographic, Phospholipids
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1575
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.