Cleared Traditional

K000754 - QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT

K000754 is an FDA 510(k) clearance for QUANTASE PHENYLALANINE SCREENING ASSAY ..., manufactured by Quantase , Ltd.. The device is a Class 2 Chemistry device with product code JNB cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K000754 · Quantase , Ltd. · Chemistry device
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Jun 2000
Decision
103d
Days
Class 2
Risk

K000754 is an FDA 510(k) clearance for the QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT. Classified as Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine (product code JNB), Class II - Special Controls.

Submitted by Quantase , Ltd. (Perth, Scotland, GB). The FDA issued a Cleared decision on June 19, 2000 after a review of 103 days - within the typical 510(k) review window.

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: 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 Quantase , Ltd. devices

FDA 510(k) Submission Details - K000754

510(k) Number K000754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2000
Decision Date June 19, 2000
Days to Decision 103 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 88d · This submission: 103d
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 8
Devices cleared under the same product code (JNB) and FDA review panel - the closest regulatory comparables to K000754.
QUANTASE PHE/GAL SCREENING ASSAY
K984463 · Quantase , Ltd. · Feb 1999
WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000
K982307 · Wallac, Inc. · Feb 1999
ACCUWELL PHENYLALANINE ASSAY
K974047 · Neometrics, Inc. · Dec 1997
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