Cleared Traditional

K926106 - IMMUCHEM PHE-MW EA

K926106 is an FDA 510(k) clearance for IMMUCHEM PHE-MW EA, manufactured by Icn Biomedicals, Inc.. The device is a Class 2 Chemistry device with product code JNB cleared through the Traditional 510(k) pathway after a 797-day FDA review.

K926106 · Icn Biomedicals, Inc. · Chemistry device
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Feb 1995
Decision
797d
Days
Class 2
Risk

K926106 is an FDA 510(k) clearance for the IMMUCHEM PHE-MW EA. Classified as Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine (product code JNB), Class II - Special Controls.

Submitted by Icn Biomedicals, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on February 8, 1995 after a review of 797 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1555 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

FDA 510(k) Submission Details - K926106

510(k) Number K926106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1992
Decision Date February 08, 1995
Days to Decision 797 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
708d slower than avg
Panel avg: 89d · This submission: 797d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JNB Device Classification - Class 2, Special Controls

Product Code JNB Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1555
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 - JNB Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine

All 14
Devices cleared under the same product code (JNB) and FDA review panel - the closest regulatory comparables to K926106.
RADIAS PHENYLALANINE TEST
K960437 · Bio-Rad · Aug 1996
QUANTASE PHENYLALANINE ASSAY
K961515 · Shield Diagnostics, Ltd. · Jun 1996
PHENYLALANINE TEST KIT
K943547 · Isolab, Inc. · Jan 1996
QUANTASE PHENYLALANINE ASSAY
K922547 · Porton Cambridge , Ltd. · Oct 1994
PHENYLALANINE (NINHYDRIN REACTION)
K891070 · Alpkem Corp. · Oct 1989
PHE/TYR KINETIC UV TEST SET
K813449 · P-L Biochemicals, Inc. · Dec 1981
K926106 · IMMUCHEM PHE-MW EA
Download PDF Icn Biomedicals, Inc.