Cleared Traditional

K891070 - PHENYLALANINE (NINHYDRIN REACTION)

K891070 is an FDA 510(k) clearance for PHENYLALANINE (NINHYDRIN REACTION), manufactured by Alpkem Corp.. The device is a Class 2 Chemistry device with product code JNB cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K891070 · Alpkem Corp. · Chemistry device
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Oct 1989
Decision
240d
Days
Class 2
Risk

K891070 is an FDA 510(k) clearance for the PHENYLALANINE (NINHYDRIN REACTION). Classified as Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine (product code JNB), Class II - Special Controls.

Submitted by Alpkem Corp. (Clackamas, US). The FDA issued a Cleared decision on October 27, 1989 after a review of 240 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 Alpkem Corp. devices

FDA 510(k) Submission Details - K891070

510(k) Number K891070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1989
Decision Date October 27, 1989
Days to Decision 240 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
152d slower than avg
Panel avg: 88d · This submission: 240d
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.