Cleared Traditional

K892930 - TECHNICON DAX TM SYSTEM ADDITIONAL ANALYTES

K892930 is an FDA 510(k) clearance for TECHNICON DAX TM SYSTEM ADDITIONAL ANALYTES, manufactured by Technicon Instruments Corp.. The device is a Class 1 Chemistry device with product code CKA cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K892930 · Technicon Instruments Corp. · Chemistry device
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Jul 1989
Decision
97d
Days
Class 1
Risk

K892930 is an FDA 510(k) clearance for the TECHNICON DAX TM SYSTEM ADDITIONAL ANALYTES. Classified as Nadh Oxidation/nad Reduction, Alt/sgpt (product code CKA), Class I - General Controls.

Submitted by Technicon Instruments Corp. (Tarrytown, US). The FDA issued a Cleared decision on July 27, 1989 after a review of 97 days - within the typical 510(k) review window.

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: 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 Technicon Instruments Corp. devices

FDA 510(k) Submission Details - K892930

510(k) Number K892930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1989
Decision Date July 27, 1989
Days to Decision 97 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
9d slower than avg
Panel avg: 88d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

CKA Device Classification - Class 1, General Controls

Product Code CKA Nadh Oxidation/nad Reduction, 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.

Regulatory Peers - CKA Nadh Oxidation/nad Reduction, Alt/sgpt

All 117
Devices cleared under the same product code (CKA) and FDA review panel - the closest regulatory comparables to K892930.
COULTER ALT (GPT) REAGENT
K897163 · Coulter Electronics, Inc. · Mar 1990
COBAS READY STAT PROFILE REAGENT STRIP
K896234 · Roche Diagnostic Systems, Inc. · Feb 1990
ALANINE AMINOTRANSFERASE (ALT)
K896001 · American Monitor Corp. · Nov 1989
ALT REAGENT (PROCEDURE NUMBER 159)
K893560 · Sigma Chemical Co. · Jul 1989
ALANINE AMINOTRANSFERASE TEST (ALT) ITEM # 65403
K893752 · Em Diagnostic Systems, Inc. · Jul 1989
ABBOTT ALT-ACTIVATED (LIQUID, LIST #01A55)
K890698 · Abbott Laboratories · Apr 1989