Cleared Traditional

K923879 - ASSAY SOFTWARE FOR DPC-MARJ5 ALASTAT EIA SOFTWARE

K923879 is an FDA 510(k) clearance for ASSAY SOFTWARE FOR DPC-MARJ5 ALASTAT EI..., manufactured by Diagnostic Products Corp.. The device is a Class 1 Chemistry device with product code JQW cleared through the Traditional 510(k) pathway after a 126-day FDA review.

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

FDA 510(k) Submission Details - K923879

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.

JQW Device Classification - Class 1, General Controls

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 83
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