Cleared Traditional

K942048 - ROCHE AMMONIA (VARIOUS)

K942048 is an FDA 510(k) clearance for ROCHE AMMONIA (VARIOUS), manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K942048

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.

DKB Device Classification - Class 2, Special Controls

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 87
Devices cleared under the same product code (DKB) and FDA review panel - the closest regulatory comparables to K942048.
EMIT IIC CALIBRATORS
K935192 · Syva Co. · Mar 1995
DRUGS OF ABUSE CALIBRATOR
K950139 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1995
DOA - IMMUNOASSAY CUT-OFF CALIBRATOR
K945289 · Medi-Tech, Inc. · Dec 1994
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