Cleared Traditional

K972015 - HYDRAGEL 7,15,30, CHOL-HDL KIT

K972015 is an FDA 510(k) clearance for HYDRAGEL 7, manufactured by Morax. The device is a Class 1 Chemistry device with product code LBT cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K972015 · Morax · Chemistry device
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Oct 1997
Decision
150d
Days
Class 1
Risk

K972015 is an FDA 510(k) clearance for the HYDRAGEL 7,15,30, CHOL-HDL KIT. Classified as Electrophoresis, Cholesterol Via Esterase-oxidase, Hdl (product code LBT), Class I - General Controls.

Submitted by Morax (Chelsea, US). The FDA issued a Cleared decision on October 27, 1997 after a review of 150 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 Morax devices

FDA 510(k) Submission Details - K972015

510(k) Number K972015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1997
Decision Date October 27, 1997
Days to Decision 150 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
62d slower than avg
Panel avg: 88d · This submission: 150d
Pathway characteristics
Predicate-based equivalence.

LBT Device Classification - Class 1, General Controls

Product Code LBT Electrophoresis, Cholesterol Via Esterase-oxidase, 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 - LBT Electrophoresis, Cholesterol Via Esterase-oxidase, Hdl

All 7
Devices cleared under the same product code (LBT) and FDA review panel - the closest regulatory comparables to K972015.
HDL CHOLESTEROL PLUS
K000568 · Roche Diagnostics Corp. · Aug 2000
HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LDL/HDL CHOL DIRECT 0
K990250 · Morax · Jun 1999
REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM
K904035 · Helena Laboratories · Nov 1990
REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187
K894366 · Helena Laboratories · Aug 1989
REP HDL ELECTROPHORESIS METHOD
K882368 · Helena Laboratories · Aug 1988
TITAN GEL HDL CHOLESTEROL KIT
K873547 · Helena Laboratories · Oct 1987