Cleared Traditional

K842018 - ISO-SEP SYSTEM

K842018 is an FDA 510(k) clearance for ISO-SEP SYSTEM, manufactured by Berwick Medical Products, Inc.. The device is a Class 2 Chemistry device with product code CEX cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K842018 · Berwick Medical Products, Inc. · Chemistry device
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Sep 1984
Decision
133d
Days
Class 2
Risk

K842018 is an FDA 510(k) clearance for the ISO-SEP SYSTEM. Classified as Chromatographic Separation, Lactate Dehydrogenase Isoenzymes (product code CEX), Class II - Special Controls.

Submitted by Berwick Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 28, 1984 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1445 - 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 Berwick Medical Products, Inc. devices

FDA 510(k) Submission Details - K842018

510(k) Number K842018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1984
Decision Date September 28, 1984
Days to Decision 133 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 88d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CEX Device Classification - Class 2, Special Controls

Product Code CEX Chromatographic Separation, Lactate Dehydrogenase Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1445
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CEX Chromatographic Separation, Lactate Dehydrogenase Isoenzymes

Devices cleared under the same product code (CEX) and FDA review panel - the closest regulatory comparables to K842018.
LACTATE DEHYDROGENASE ISOENZYME 1
K872891 · Data Medical Associates, Inc. · Sep 1987
LD-1(IMMUNO) SEPARATION SET
K851521 · Seragen Diagnostics, Inc. · May 1985
TITAN GEL LDH ISOENZYME KIT
K821983 · Helena Laboratories · Dec 1982
ULTRACHEM T.P.
K821879 · Harleco Diagnostics · Jul 1982
CENTRIFICHEM CREATININE
K800129 · Union Carbide Corp. · Feb 1980