Cleared Abbreviated

K021607 - RDI HS CRP CALIBRATOR SET

K021607 is an FDA 510(k) clearance for RDI HS CRP CALIBRATOR SET, manufactured by Reference Diagnostics, Inc.. The device is a Class 2 Immunology device with product code JIT cleared through the Abbreviated 510(k) pathway after a 42-day FDA review.

K021607 · Reference Diagnostics, Inc. · Immunology device
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Jun 2002
Decision
42d
Days
Class 2
Risk

K021607 is an FDA 510(k) clearance for the RDI HS CRP CALIBRATOR SET. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Reference Diagnostics, Inc. (Bedford, US). The FDA issued a Cleared decision on June 27, 2002 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1150 - the FDA immunology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Reference Diagnostics, Inc. devices

FDA 510(k) Submission Details - K021607

510(k) Number K021607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2002
Decision Date June 27, 2002
Days to Decision 42 days
Submission Type Abbreviated
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 105d · This submission: 42d
Pathway characteristics
Standards-based clearance path.

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 Immunology devices follow this clearance model.

Regulatory Peers - JIT Calibrator, Secondary

All 206
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K021607.
RDI EXTENDED RANGE CRP CALIBRATOR SET
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K020723 · Dade Behring, Inc. · May 2002
CHEMISTRY CALIBRATOR
K020454 · Jas Diagnostics, Inc. · Apr 2002