Cleared Traditional

K790865 - LANCER HDL SEPARATION KIT

K790865 is the FDA 510(k) clearance for LANCER HDL SEPARATION KIT by Sherwood Medical Co.. It is a Class 1 Chemistry device (product code LBR) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K790865 · Sherwood Medical Co. · Chemistry device
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Jun 1979
Decision
52d
Days
Class 1
Risk

K790865 is an FDA 510(k) clearance for the LANCER HDL SEPARATION KIT. Classified as Ldl & Vldl Precipitation, Hdl (product code LBR), Class I - General Controls.

Submitted by Sherwood Medical Co. (Mchenry, US). The FDA issued a Cleared decision on June 28, 1979 after a review of 52 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 Sherwood Medical Co. devices

Submission Details

510(k) Number K790865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1979
Decision Date June 28, 1979
Days to Decision 52 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
36d faster than avg
Panel avg: 88d · This submission: 52d
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 K790865.
HDL CHOLESTEROL REAGENT
K812574 · Pointe Scientific, Inc., · Sep 1981
HDL REAGENT
K800996 · Gilford Diagnostics · May 1980
CHOL-HDL TEST, HIGH LIPO. CHOL TEST
K792313 · Sclavo, Inc. · Dec 1979
H-D-EL
K790372 · General Diagnostics · May 1979
A-GENT-HDL REAGENT
K790329 · Abbott Laboratories · Apr 1979
HDL CENTRIFIKIT
K781093 · Beckman Instruments, Inc. · Aug 1978