Cleared Traditional

K993210 - ACCESS HYBRITECH FREE PSA QC

K993210 is the FDA 510(k) clearance for ACCESS HYBRITECH FREE PSA QC by Beckman Coulter, Inc.. It is a Class 1 Immunology device (product code JJX) cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K993210 · Beckman Coulter, Inc. · Immunology device
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Jan 2000
Decision
103d
Days
Class 1
Risk

K993210 is an FDA 510(k) clearance for the ACCESS HYBRITECH FREE PSA QC, MODEL 37219. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on January 5, 2000 after a review of 103 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Beckman Coulter, Inc. devices

Submission Details

510(k) Number K993210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1999
Decision Date January 05, 2000
Days to Decision 103 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
1d faster than avg
Panel avg: 104d · This submission: 103d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
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 - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 370
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K993210.
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VITROS IMMUNODIAGNOSTIC PRODUCTS CEA RANGE VERIFIERS
K990984 · Ortho-Clinical Diagnostics, Inc. · Apr 1999