Cleared Traditional

K893740 - LIPIDIRECT LOW DENSITY LIPOPROTEIN CHOLESTEROL TES

K893740 is an FDA 510(k) clearance for LIPIDIRECT LOW DENSITY LIPOPROTEIN CHOL..., manufactured by Reference Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code MRR cleared through the Traditional 510(k) pathway after a 306-day FDA review.

K893740 · Reference Diagnostics, Inc. · Chemistry device
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Mar 1990
Decision
306d
Days
Class 1
Risk

K893740 is an FDA 510(k) clearance for the LIPIDIRECT LOW DENSITY LIPOPROTEIN CHOLESTEROL TES. Classified as System, Test, Low Density, Lipoprotein (product code MRR), Class I - General Controls.

Submitted by Reference Diagnostics, Inc. (Arlington, US). The FDA issued a Cleared decision on March 19, 1990 after a review of 306 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1475 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Reference Diagnostics, Inc. devices

FDA 510(k) Submission Details - K893740

510(k) Number K893740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1989
Decision Date March 19, 1990
Days to Decision 306 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
218d slower than avg
Panel avg: 88d · This submission: 306d
Pathway characteristics
Predicate-based equivalence.

MRR Device Classification - Class 1, General Controls

Product Code MRR System, Test, Low Density, Lipoprotein
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1475
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.