Cleared Traditional

K940679 - REP HDL/LDL-30 KIT - CAT. NO. 3220

K940679 is the FDA 510(k) clearance for REP HDL/LDL-30 KIT - CAT. NO. 3220 by Helena Laboratories. It is a Class 1 Chemistry device (product code JHO) cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K940679 · Helena Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1994
Decision
212d
Days
Class 1
Risk

K940679 is an FDA 510(k) clearance for the REP HDL/LDL-30 KIT - CAT. NO. 3220,3221,3222. 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 September 9, 1994 after a review of 212 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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

Submission Details

510(k) Number K940679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1994
Decision Date September 09, 1994
Days to Decision 212 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
124d slower than avg
Panel avg: 88d · This submission: 212d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 19
Devices cleared under the same product code (JHO) and FDA review panel - the closest regulatory comparables to K940679.
REP FLUR CHOLESTEROL-60 KIT
K964471 · Helena Laboratories · Dec 1996
RAPID ELECTROPHORESIS ANALYZER
K960571 · Helena Laboratories · Oct 1996
REP DIRECT-SEP CHOLESTEROL-15 KIT
K935162 · Helena Laboratories · Nov 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
TITAN GEL MULTI-SLOT LIPO-17 SYSTEM
K871319 · Helena Laboratories · Apr 1987