Cleared Traditional

K021163 - OCTEIA 25-HYDROXY VITAMIN D

K021163 is an FDA 510(k) clearance for OCTEIA 25-HYDROXY VITAMIN D, manufactured by Immunodiagnostic Systems , Ltd.. The device is a Class 2 Chemistry device with product code MRG cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K021163 · Immunodiagnostic Systems , Ltd. · Chemistry device
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May 2002
Decision
29d
Days
Class 2
Risk

K021163 is an FDA 510(k) clearance for the OCTEIA 25-HYDROXY VITAMIN D. Classified as System, Test, Vitamin D (product code MRG), Class II - Special Controls.

Submitted by Immunodiagnostic Systems , Ltd. (Boldon, Tyne & Wear, GB). The FDA issued a Cleared decision on May 10, 2002 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1825 - 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 Immunodiagnostic Systems , Ltd. devices

FDA 510(k) Submission Details - K021163

510(k) Number K021163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2002
Decision Date May 10, 2002
Days to Decision 29 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 88d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

MRG Device Classification - Class 2, Special Controls

Product Code MRG System, Test, Vitamin D
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1825
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 Consultant

Underwriters Laboratories, Inc.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MRG System, Test, Vitamin D

All 44
Devices cleared under the same product code (MRG) and FDA review panel - the closest regulatory comparables to K021163.
1,25-DIHYDROXY VITAMIN D EIA
K051110 · Immunodiagnostic Systems , Ltd. · Jul 2005
GAMMA-B 1,25-DIHYDROXY VITAMIN D
K042519 · Immunodiagnostic Systems , Ltd. · Dec 2004
LIAISON 25 OH VITAMIN D
K032844 · DiaSorin, Inc. · Feb 2004
1,25-DIHYDROXYVITAMIN D125I RIA
K014030 · DiaSorin, Inc. · Mar 2002
GAMMA-B 25-HYDROXY VITAMIN D RIA
K991998 · Immunodiagnostic Systems , Ltd. · Sep 1999
INCSTAR 25-HYDROXYVITMIN D 1251 RIA
K953567 · Incstar Corp. · Sep 1996