Cleared Traditional

QUANTASE PHENYLALANINE ASSAY (K922547) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K922547 · Porton Cambridge , Ltd. · Chemistry device
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Oct 1994
Decision
864d
Days
Class 2
Risk

K922547 is an FDA 510(k) clearance for the QUANTASE PHENYLALANINE ASSAY. Classified as Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine (product code JNB), Class II - Special Controls.

Submitted by Porton Cambridge , Ltd. (Cb8 7pw, United Kingdom, GB). The FDA issued a Cleared decision on October 13, 1994 after a review of 864 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.

View all Porton Cambridge , Ltd. devices

Submission Details

510(k) Number K922547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1992
Decision Date October 13, 1994
Days to Decision 864 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
776d slower than avg
Panel avg: 88d · This submission: 864d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.