Cleared Traditional

K953567 - INCSTAR 25-HYDROXYVITMIN D 1251 RIA

K953567 is the FDA 510(k) clearance for INCSTAR 25-HYDROXYVITMIN D 1251 RIA by Incstar Corp.. It is a Class 2 Chemistry device (product code MRG) cleared through the Traditional 510(k) pathway after a 422-day FDA review.

K953567 · Incstar Corp. · Chemistry device
Download Printable Device Report (PDF)
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Sep 1996
Decision
422d
Days
Class 2
Risk

K953567 is an FDA 510(k) clearance for the INCSTAR 25-HYDROXYVITMIN D 1251 RIA. Classified as System, Test, Vitamin D (product code MRG), Class II - Special Controls.

Submitted by Incstar Corp. (Stillwater, US). The FDA issued a Cleared decision on September 25, 1996 after a review of 422 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Incstar Corp. devices

Submission Details

510(k) Number K953567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1995
Decision Date September 25, 1996
Days to Decision 422 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
334d slower than avg
Panel avg: 88d · This submission: 422d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.