Cleared Traditional

K981854 - OLYMPUS SERUM PROTEIN MULTICALIBRATOR,

K981854 is an FDA 510(k) clearance for OLYMPUS SERUM PROTEIN MULTICALIBRATOR, manufactured by Olympus Diagnostica GmbH. The device is a Class 2 Chemistry device with product code JIT cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K981854 · Olympus Diagnostica GmbH · Chemistry device
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Aug 1998
Decision
84d
Days
Class 2
Risk

K981854 is an FDA 510(k) clearance for the OLYMPUS SERUM PROTEIN MULTICALIBRATOR,. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Olympus Diagnostica GmbH (Melville, US). The FDA issued a Cleared decision on August 18, 1998 after a review of 84 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 Olympus Diagnostica GmbH devices

FDA 510(k) Submission Details - K981854

510(k) Number K981854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1998
Decision Date August 18, 1998
Days to Decision 84 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 88d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIT Device Classification - Class 2, Special Controls

Product Code JIT Calibrator, Secondary
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 - JIT Calibrator, Secondary

All 208
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K981854.
DIMENSIONS (R) RXL CARDIAC TROPONIN I CALIBRATOR
K983693 · Dade Behring, Inc. · Nov 1998
STRATUS CS TROPONIN I CALIBRATOR
K983722 · Dade Behring, Inc. · Nov 1998
FERRITIN CALIBRATOR
K983548 · Dade Behring, Inc. · Oct 1998
PREALBUMIN CALIBRATOR
K982292 · Dade Behring, Inc. · Aug 1998
STRATUS CS CKMB CALPAK
K981097 · Dade Behring, Inc. · Apr 1998
STRATUS CS TROP CALPAK
K981100 · Dade Behring, Inc. · Apr 1998