Cleared Traditional

K990608 - ARCHITECT CEA MASTERCHECK

K990608 is the FDA 510(k) clearance for ARCHITECT CEA MASTERCHECK by Bio-Rad. It is a Class 1 Chemistry device (product code JJX) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K990608 · Bio-Rad · Chemistry device

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Mar 1999

Decision

34d

Days

Class 1

Risk

K990608 is an FDA 510(k) clearance for the ARCHITECT CEA MASTERCHECK, MODEL 6CO2-05. 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 March 30, 1999 after a review of 34 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	K990608 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 24, 1999
Decision Date	March 30, 1999
Days to Decision	34 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

54d faster than avg

Panel avg: 88d · This submission: 34d

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 K990608.

ELECSYS PARATHYROID HORMONE CALCHECK

K993642 · Roche Diagnostics Corp. · Nov 1999

TURBIDIMETRIC/NEPHELOMETRIC HUMAN SERUM REFERENCE PREPARATION

K981914 · The Binding Site, Ltd. · Nov 1999

VITROS IMMUNODIAGNOSTIC PRODUCTS CEA RANGE VERIFIERS

K990984 · Ortho-Clinical Diagnostics, Inc. · Apr 1999

VITROS IMMUNODIAGNOSTIC PRODUCTS CA15-3 RANGE VERIFIERS, CA125 II RANGE VERIFIERS, PSA RANGE VERIFIERS

K990783 · Ortho-Clinical Diagnostics, Inc. · Mar 1999

ARCHITECT PROGESTERONE MASTERCHECK MODEL #6C26-05

K990393 · Bio-Rad · Mar 1999

SAS HCG SERUM CONTROLS

K990720 · Sa Scientific, Inc. · Mar 1999

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K990608

Bio-Rad

Irvine, CA · US

ELIZABETH PLATT

Regulatory profile

319 submissions 319 cleared

100% clearance rate · Active in Chemistry

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