Cleared Traditional

K943547 - PHENYLALANINE TEST KIT

K943547 is an FDA 510(k) clearance for PHENYLALANINE TEST KIT, manufactured by Isolab, Inc.. The device is a Class 2 Chemistry device with product code JNB cleared through the Traditional 510(k) pathway after a 554-day FDA review.

K943547 · Isolab, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
554d
Days
Class 2
Risk

K943547 is an FDA 510(k) clearance for the PHENYLALANINE TEST KIT. Classified as Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine (product code JNB), Class II - Special Controls.

Submitted by Isolab, Inc. (Akron, US). The FDA issued a Cleared decision on January 26, 1996 after a review of 554 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 - K943547

510(k) Number K943547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1994
Decision Date January 26, 1996
Days to Decision 554 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
465d slower than avg
Panel avg: 89d · This submission: 554d
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 K943547.
MANUAL PHENYLALANINE TEST
K963040 · Bio-Rad · Oct 1996
RADIAS PHENYLALANINE TEST
K960437 · Bio-Rad · Aug 1996
QUANTASE PHENYLALANINE ASSAY
K961515 · Shield Diagnostics, Ltd. · Jun 1996
IMMUCHEM PHE-MW EA
K926106 · Icn Biomedicals, Inc. · Feb 1995
QUANTASE PHENYLALANINE ASSAY
K922547 · Porton Cambridge , Ltd. · Oct 1994
PHENYLALANINE (NINHYDRIN REACTION)
K891070 · Alpkem Corp. · Oct 1989
K943547 · PHENYLALANINE TEST KIT
Download PDF Isolab, Inc.