Cleared Traditional

K021541 - NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT

K021541 is an FDA 510(k) clearance for NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT, manufactured by Perkinelmer Life Sciences. The device is a Class 2 Chemistry device with product code JNB cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K021541 · Perkinelmer Life Sciences · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
171d
Days
Class 2
Risk

K021541 is an FDA 510(k) clearance for the NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT. Classified as Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine (product code JNB), Class II - Special Controls.

Submitted by Perkinelmer Life Sciences (Norton, US). The FDA issued a Cleared decision on October 28, 2002 after a review of 171 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 Perkinelmer Life Sciences devices

FDA 510(k) Submission Details - K021541

510(k) Number K021541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2002
Decision Date October 28, 2002
Days to Decision 171 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 88d · This submission: 171d
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 K021541.
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