Cleared Traditional

K023860 - MICROALBUMIN REAGENT SET AND CALIBRATORS

K023860 is an FDA 510(k) clearance for MICROALBUMIN REAGENT SET AND CALIBRATORS, manufactured by Pointe Scientific, Inc.,. The device is a Class 2 Chemistry device with product code DDZ cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K023860 · Pointe Scientific, Inc., · Chemistry device
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Apr 2003
Decision
159d
Days
Class 2
Risk

K023860 is an FDA 510(k) clearance for the MICROALBUMIN REAGENT SET AND CALIBRATORS. Classified as Albumin, Fitc, Antigen, Antiserum, Control (product code DDZ), Class II - Special Controls.

Submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on April 28, 2003 after a review of 159 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5040 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Pointe Scientific, Inc., devices

FDA 510(k) Submission Details - K023860

510(k) Number K023860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2002
Decision Date April 28, 2003
Days to Decision 159 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 88d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DDZ Device Classification - Class 2, Special Controls

Product Code DDZ Albumin, Fitc, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5040
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.