Cleared Traditional

K800996 - HDL REAGENT

K800996 is an FDA 510(k) clearance for HDL REAGENT, manufactured by Gilford Diagnostics. The device is a Class 1 Chemistry device with product code LBR cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K800996 · Gilford Diagnostics · Chemistry device
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May 1980
Decision
19d
Days
Class 1
Risk

K800996 is an FDA 510(k) clearance for the HDL REAGENT. Classified as Ldl & Vldl Precipitation, Hdl (product code LBR), Class I - General Controls.

Submitted by Gilford Diagnostics (Mchenry, US). The FDA issued a Cleared decision on May 14, 1980 after a review of 19 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.

View all Gilford Diagnostics devices

FDA 510(k) Submission Details - K800996

510(k) Number K800996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1980
Decision Date May 14, 1980
Days to Decision 19 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
69d faster than avg
Panel avg: 88d · This submission: 19d
Pathway characteristics
Predicate-based equivalence.

LBR Device Classification - Class 1, General Controls

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 53
Devices cleared under the same product code (LBR) and FDA review panel - the closest regulatory comparables to K800996.
HDL PRECIPITANT REAGENT SET
K821203 · Omega Medical Electronics · Jul 1982
HDL CHOLESTEROL REAGENT SET
K812839 · Anco Medical Reagents & Assoc. · Dec 1981
HDL CHOLESTEROL REAGENT
K812574 · Pointe Scientific, Inc., · Sep 1981
CHOL-HDL TEST, HIGH LIPO. CHOL TEST
K792313 · Sclavo, Inc. · Dec 1979
LANCER HDL SEPARATION KIT
K790865 · Sherwood Medical Co. · Jun 1979
H-D-EL
K790372 · General Diagnostics · May 1979