Cleared Traditional

K941192 - ORTHO ALT MICROWELL TEST SYSTEM (FDA 510(k) Clearance)

Class I Chemistry device.

K941192 · Ortho Diagnostic Systems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
428d
Days
Class 1
Risk

K941192 is an FDA 510(k) clearance for the ORTHO ALT MICROWELL TEST SYSTEM. Classified as Hydrazone Colorimetry, Alt/sgpt (product code CKD), Class I - General Controls.

Submitted by Ortho Diagnostic Systems, Inc. (Raritan, US). The FDA issued a Cleared decision on May 16, 1995 after a review of 428 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1030 - 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 Ortho Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K941192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1994
Decision Date May 16, 1995
Days to Decision 428 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
340d slower than avg
Panel avg: 88d · This submission: 428d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CKD Hydrazone Colorimetry, Alt/sgpt
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1030
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.