Cleared Traditional

B2-MICROGLOBULIN CONTROL SET SERUM (K982471) - FDA 510(k) Clearance

Class I Chemistry device.

K982471 · Boehringer Mannheim Corp. · Chemistry device

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Optimized for regulatory review, auditing and printing

Aug 1998

Decision

21d

Days

Class 1

Risk

K982471 is an FDA 510(k) clearance for the B2-MICROGLOBULIN CONTROL SET SERUM. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Pleasanton, US). The FDA issued a Cleared decision on August 6, 1998 after a review of 21 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 Boehringer Mannheim Corp. devices

Submission Details

510(k) Number	K982471 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 16, 1998
Decision Date	August 06, 1998
Days to Decision	21 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

67d faster than avg

Panel avg: 88d · This submission: 21d

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 194

Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K982471.

ARCHITECT TSH MASTERCHECK, LIST NO, 6C52-05

K984072 · Bio-Rad · Nov 1998

CARDIAC MARKER CONTROL MODULE, MODEL CCCM

K983971 · Diagnostic Products Corp. · Nov 1998

ARCHITECT TESTOSTERONE MASTERCHECK, MODEL 6C28-05

K983578 · Bio-Rad · Nov 1998

DADE TRU-LIQUID CARDIAC CONTROL

K982591 · Dade Behring, Inc. · Aug 1998

VIGIL HEMOGLOBIN (HBALC) CONTROLS

K982022 · Beckman Coulter, Inc. · Jul 1998

ACCESS AFP QC ON THE ACCESS IMMUNOASSAY ANALYZER, MODEL NUMBER 33219

K981864 · Beckman Coulter, Inc. · Jun 1998

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 K982471

Boehringer Mannheim Corp.

Pleasanton, CA · US

JULIE A SMITH

Regulatory profile

340 submissions 340 cleared

100% clearance rate · Active in Chemistry

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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