Cleared Traditional

K790372 - H-D-EL

K790372 is the FDA 510(k) clearance for H-D-EL by General Diagnostics. It is a Class 1 Chemistry device (product code LBR) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K790372 · General Diagnostics · Chemistry device
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May 1979
Decision
69d
Days
Class 1
Risk

K790372 is an FDA 510(k) clearance for the H-D-EL. Classified as Ldl & Vldl Precipitation, Hdl (product code LBR), Class I - General Controls.

Submitted by General Diagnostics (Mchenry, US). The FDA issued a Cleared decision on May 3, 1979 after a review of 69 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K790372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1979
Decision Date May 03, 1979
Days to Decision 69 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
19d faster than avg
Panel avg: 88d · This submission: 69d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LBR Ldl & Vldl Precipitation, Hdl
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.

Regulatory Peers - LBR Ldl & Vldl Precipitation, Hdl

All 33
Devices cleared under the same product code (LBR) and FDA review panel - the closest regulatory comparables to K790372.
HDL REAGENT
K800996 · Gilford Diagnostics · May 1980
CHOL-HDL TEST, HIGH LIPO. CHOL TEST
K792313 · Sclavo, Inc. · Dec 1979
LANCER HDL SEPARATION KIT
K790865 · Sherwood Medical Co. · Jun 1979
A-GENT-HDL REAGENT
K790329 · Abbott Laboratories · Apr 1979
HDL CENTRIFIKIT
K781093 · Beckman Instruments, Inc. · Aug 1978