Cleared Traditional

STAT PROFILE PLUS 9 ANALYZER (K936066) - FDA 510(k) Clearance

Class I Chemistry device.

K936066 · Nova Biomedical Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
443d
Days
Class 1
Risk

K936066 is an FDA 510(k) clearance for the STAT PROFILE PLUS 9 ANALYZER. Classified as Acid, Lactic, Enzymatic Method (product code KHP), Class I - General Controls.

Submitted by Nova Biomedical Corp. (Walham, US). The FDA issued a Cleared decision on March 9, 1995 after a review of 443 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1450 - 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 Nova Biomedical Corp. devices

Submission Details

510(k) Number K936066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1993
Decision Date March 09, 1995
Days to Decision 443 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
355d slower than avg
Panel avg: 88d · This submission: 443d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KHP Acid, Lactic, Enzymatic Method
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1450
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.