Cleared Traditional

K982307 - WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000

K982307 is an FDA 510(k) clearance for WALLAC NEONATAL LEUCINE TEST KIT MODEL ..., manufactured by Wallac, Inc.. The device is a Class 2 Chemistry device with product code JNB cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K982307 · Wallac, Inc. · Chemistry device
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Feb 1999
Decision
216d
Days
Class 2
Risk

K982307 is an FDA 510(k) clearance for the WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000. Classified as Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine (product code JNB), Class II - Special Controls.

Submitted by Wallac, Inc. (Norton, US). The FDA issued a Cleared decision on February 2, 1999 after a review of 216 days - an extended review cycle.

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 Wallac, Inc. devices

FDA 510(k) Submission Details - K982307

510(k) Number K982307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1998
Decision Date February 02, 1999
Days to Decision 216 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
128d slower than avg
Panel avg: 88d · This submission: 216d
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 7
Devices cleared under the same product code (JNB) and FDA review panel - the closest regulatory comparables to K982307.
QUANTASE PHE/GAL SCREENING ASSAY
K984463 · Quantase , Ltd. · 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
PHENYLALANINE TEST KIT
K943547 · Isolab, Inc. · Jan 1996