Cleared Traditional

K042625 - QUIKREAD CRP CALIBRATOR SET

K042625 is an FDA 510(k) clearance for QUIKREAD CRP CALIBRATOR SET, manufactured by Orion Diagnostica, OY. The device is a Class 1 Chemistry device with product code JJY cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K042625 · Orion Diagnostica, OY · Chemistry device
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Nov 2004
Decision
52d
Days
Class 1
Risk

K042625 is an FDA 510(k) clearance for the QUIKREAD CRP CALIBRATOR SET. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Orion Diagnostica, OY (Espoo, FI). The FDA issued a Cleared decision on November 18, 2004 after a review of 52 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 Orion Diagnostica, OY devices

FDA 510(k) Submission Details - K042625

510(k) Number K042625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2004
Decision Date November 18, 2004
Days to Decision 52 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 88d · This submission: 52d
Pathway characteristics
Predicate-based equivalence.

JJY Device Classification - Class 1, General Controls

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
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 - JJY Multi-analyte Controls, All Kinds (assayed)

All 553
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K042625.
LIQUID ASSAYED MULTIQUAL CONTROL
K043208 · Bio-Rad · Jan 2005
AUDIT MICROCV GENERAL CHEMISTRY LINEARITY SET
K042318 · Aalto Scientific, Ltd. · Dec 2004
LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL
K043108 · Bio-Rad Laboratories, Inc. · Dec 2004
QUEST TUMOR MARKER CONTROL, MODEL 955
K042815 · Bio-Rad · Nov 2004
VALIDATE LIPOPROTEIN CALIBRATION VERIFICATION TEST SET, MODEL 501
K041975 · Maine Standards Co. · Oct 2004
LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CONTROL, LEVEL 4, 5
K042324 · Bio-Rad · Oct 2004