Cleared Traditional

K935162 - REP DIRECT-SEP CHOLESTEROL-15 KIT

Also marketed or referenced as:
CHOLESTEROL-8 KIT CHOLESTEROL-4 KIT

K935162 is an FDA 510(k) clearance for REP DIRECT-SEP CHOLESTEROL-15 KIT, manufactured by Helena Laboratories. The device is a Class 1 Chemistry device with product code JHO cleared through the Traditional 510(k) pathway after a 377-day FDA review.

K935162 · Helena Laboratories · Chemistry device
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Nov 1994
Decision
377d
Days
Class 1
Risk

K935162 is an FDA 510(k) clearance for the REP DIRECT-SEP CHOLESTEROL-15 KIT. Classified as Electrophoretic Separation, Lipoproteins (product code JHO), Class I - General Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on November 10, 1994 after a review of 377 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 Helena Laboratories devices

FDA 510(k) Submission Details - K935162

510(k) Number K935162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1993
Decision Date November 10, 1994
Days to Decision 377 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
289d slower than avg
Panel avg: 88d · This submission: 377d
Pathway characteristics
Predicate-based equivalence.

JHO Device Classification - Class 1, General Controls

Product Code JHO Electrophoretic Separation, Lipoproteins
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 - JHO Electrophoretic Separation, Lipoproteins

All 24
Devices cleared under the same product code (JHO) and FDA review panel - the closest regulatory comparables to K935162.
REP FLUR CHOLESTEROL-60 KIT
K964471 · Helena Laboratories · Dec 1996
RAPID ELECTROPHORESIS ANALYZER
K960571 · Helena Laboratories · Oct 1996
LFS LIPOGEL ASSAY KIT
K960785 · Zaxis, Inc. · Sep 1996
REP HDL/LDL-30 KIT - CAT. NO. 3220,3221,3222
K940679 · Helena Laboratories · Sep 1994
REP LIPO-8 KIT, NO. 3182/REP LIPO-16 KIT, NO. 3181
K893223 · Helena Laboratories · Jun 1989
REP LIPO KIT CAT. NO 3180
K881809 · Helena Laboratories · Jun 1988