Cleared Traditional

MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR (K984425) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K984425 · Boehringer Mannheim Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1999
Decision
40d
Days
Class 2
Risk

K984425 is an FDA 510(k) clearance for the MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on January 20, 1999 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 K984425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1998
Decision Date January 20, 1999
Days to Decision 40 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
48d faster than avg
Panel avg: 88d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIX Calibrator, Multi-analyte Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JIX Calibrator, Multi-analyte Mixture

All 106
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K984425.
OLYMPUS SERUM PROTEIN MULTICALIBRATOR 2
K992086 · Olympus America, Inc. · Aug 1999
MODIFICATION OF N PROTEIN STANDARD SL
K991181 · Dade Behring, Inc. · Jun 1999
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.)
K990460 · Roche Diagnostics Corp. · Mar 1999
SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2
K984014 · Beckman Coulter, Inc. · Dec 1998
PRECISET SERUM PROTEINS CALIBRATOR
K983469 · Boehringer Mannheim Corp. · Nov 1998
AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 2
K981706 · Abbott Laboratories · Jul 1998