Cleared Traditional

K030546 - CRP (II) CALIBRATORS

K030546 is an FDA 510(k) clearance for CRP (II) CALIBRATORS, manufactured by Denka Seiken Co., Ltd.. The device is a Class 2 Immunology device with product code JIS cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K030546 · Denka Seiken Co., Ltd. · Immunology device
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Jun 2003
Decision
102d
Days
Class 2
Risk

K030546 is an FDA 510(k) clearance for the CRP (II) CALIBRATORS. Classified as Calibrator, Primary (product code JIS), Class II - Special Controls.

Submitted by Denka Seiken Co., Ltd. (Gosen City, Niigata, JP). The FDA issued a Cleared decision on June 2, 2003 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1150 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Denka Seiken Co., Ltd. devices

FDA 510(k) Submission Details - K030546

510(k) Number K030546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2003
Decision Date June 02, 2003
Days to Decision 102 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 105d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIS Device Classification - Class 2, Special Controls

Product Code JIS Calibrator, Primary
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 Immunology devices follow this clearance model.

Regulatory Peers - JIS Calibrator, Primary

All 113
Devices cleared under the same product code (JIS) and FDA review panel - the closest regulatory comparables to K030546.
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