Cleared Traditional

K984626 - ARCHITECT B12 MASTERCHEK

K984626 is the FDA 510(k) clearance for ARCHITECT B12 MASTERCHEK by Bio-Rad. It is a Class 1 Chemistry device (product code JJX) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K984626 · Bio-Rad · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1999
Decision
32d
Days
Class 1
Risk

K984626 is an FDA 510(k) clearance for the ARCHITECT B12 MASTERCHEK, MODEL # 6C09-O5. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Bio-Rad (Irvine, US). The FDA issued a Cleared decision on January 29, 1999 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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: 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 Bio-Rad devices

Submission Details

510(k) Number K984626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1998
Decision Date January 29, 1999
Days to Decision 32 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 88d · This submission: 32d
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 K984626.
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K984604 · Bio-Rad · Feb 1999
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K984625 · Bio-Rad · Feb 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE VERIFIERS, VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS
K990026 · Ortho-Clinical Diagnostics, Inc. · Jan 1999
ABBOTT LIQUID AMMONIA CONTROL, MODEL #'S 1E93-01,1E94-01,1E95-01
K990162 · Bio-Rad · Jan 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS AFP RANGE VERIFIERS
K990061 · Ortho-Clinical Diagnostics, Inc. · Jan 1999