Cleared Traditional

K924919 - DADE(R) TUMOR MARKER CONTROL

K924919 is an FDA 510(k) clearance for DADE TUMOR MARKER CONTROL, manufactured by Baxter Diagnostics, Inc.. The device is a Class 1 Immunology device with product code JJY cleared through the Traditional 510(k) pathway after a 310-day FDA review.

K924919 · Baxter Diagnostics, Inc. · Immunology device
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Aug 1993
Decision
310d
Days
Class 1
Risk

K924919 is an FDA 510(k) clearance for the DADE(R) TUMOR MARKER CONTROL. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Baxter Diagnostics, Inc. (Miami, US). The FDA issued a Cleared decision on August 5, 1993 after a review of 310 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1660 - the FDA immunology device 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Baxter Diagnostics, Inc. devices

FDA 510(k) Submission Details - K924919

510(k) Number K924919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1992
Decision Date August 05, 1993
Days to Decision 310 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
205d slower than avg
Panel avg: 105d · This submission: 310d
Pathway characteristics
Predicate-based equivalence.

JJY Device Classification - Class 1, General Controls

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJY Multi-analyte Controls, All Kinds (assayed)

All 594
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