Cleared Traditional

CRPEX CRP CONTROLS LEVEL L, M, H (K022725) - FDA 510(k) Clearance

Also marketed or referenced as:
CAT. NO.: 3011, 3012, 3013

Class I Immunology device.

K022725 · Good Biotech Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
38d
Days
Class 1
Risk

K022725 is an FDA 510(k) clearance for the CRPEX CRP CONTROLS LEVEL L, M, H. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Good Biotech Corp. (Taichung, TW). The FDA issued a Cleared decision on September 23, 2002 after a review of 38 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Good Biotech Corp. devices

Submission Details

510(k) Number K022725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2002
Decision Date September 23, 2002
Days to Decision 38 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 104d · This submission: 38d
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)

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