Cleared Traditional

ALBUMIN SCREEN TEST (K870516) - FDA 510(k) Clearance

Class I Chemistry device.

K870516 · Sclavo, Inc. · Chemistry device
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Oct 1987
Decision
258d
Days
Class 1
Risk

K870516 is an FDA 510(k) clearance for the ALBUMIN SCREEN TEST. Classified as Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.) (product code JIQ), Class I - General Controls.

Submitted by Sclavo, Inc. (Wayne, US). The FDA issued a Cleared decision on October 20, 1987 after a review of 258 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1645 - 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 Sclavo, Inc. devices

Submission Details

510(k) Number K870516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1987
Decision Date October 20, 1987
Days to Decision 258 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
170d slower than avg
Panel avg: 88d · This submission: 258d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JIQ Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1645
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.