Cleared Traditional

K942048 - ROCHE AMMONIA (VARIOUS)

K942048 is the FDA 510(k) clearance for ROCHE AMMONIA (VARIOUS) by Roche Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code DKB) cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K942048 · Roche Diagnostic Systems, Inc. · Chemistry device
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Oct 1994
Decision
159d
Days
Class 2
Risk

K942048 is an FDA 510(k) clearance for the ROCHE AMMONIA (VARIOUS). Classified as Calibrators, Drug Mixture (product code DKB), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on October 4, 1994 after a review of 159 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3200 - 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 Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K942048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1994
Decision Date October 04, 1994
Days to Decision 159 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
71d slower than avg
Panel avg: 88d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DKB Calibrators, Drug Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3200
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 - DKB Calibrators, Drug Mixture

All 75
Devices cleared under the same product code (DKB) and FDA review panel - the closest regulatory comparables to K942048.
CEDIA DAU MULTI-DR CALIBRATOR/PRI, SEC, INTER, HIGH
K954608 · Boehringer Mannheim Corp. · Dec 1995
EMIT IIC CALIBRATORS
K935192 · Syva Co. · Mar 1995
DRUGS OF ABUSE CALIBRATOR
K950139 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1995
URINE CALIBRATOR
K940935 · Diagnostic Reagents, Inc. · Jul 1994
CEDIA DAU NEGATIVE CALIBRATOR
K935793 · Microgenics Corp. · Mar 1994
CEDIA(R) DAU BAR/BENZ 300,300 INTERMED & HIGH CALIB
K936028 · Microgenics Corp. · Mar 1994