Cleared Traditional

ASSAY SOFTWARE FOR DPC-MARJ5 ALASTAT EIA SOFTWARE (K923879) - FDA 510(k) Clearance

Class I Chemistry device.

K923879 · Diagnostic Products Corp. · Chemistry device
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Dec 1992
Decision
126d
Days
Class 1
Risk

K923879 is an FDA 510(k) clearance for the ASSAY SOFTWARE FOR DPC-MARJ5 ALASTAT EIA SOFTWARE. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on December 7, 1992 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2750 - 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K923879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1992
Decision Date December 07, 1992
Days to Decision 126 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 88d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JQW Station, Pipetting And Diluting, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2750
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 - JQW Station, Pipetting And Diluting, For Clinical Use

All 139
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