Cleared Traditional

K870516 - ALBUMIN SCREEN TEST

K870516 is an FDA 510(k) clearance for ALBUMIN SCREEN TEST, manufactured by Sclavo, Inc.. The device is a Class 1 Chemistry device with product code JIQ cleared through the Traditional 510(k) pathway after a 258-day FDA review.

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

FDA 510(k) Submission Details - K870516

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
170d slower than avg
Panel avg: 88d · This submission: 258d
Pathway characteristics
Predicate-based equivalence.

JIQ Device Classification - Class 1, General Controls

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.

Regulatory Peers - JIQ Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.)

All 11
Devices cleared under the same product code (JIQ) and FDA review panel - the closest regulatory comparables to K870516.
RAICHEM(TM) SPIA(TM) MICROALBULMIN REAGENT
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WAKO(TM) MICRO-ALBUMIN
K902216 · Wako Chemicals USA, Inc. · Jun 1990
BECKMAN MA MICROALBUMIN REAGENT KIT
K895883 · Beckman Instruments, Inc. · Dec 1989
SULFOSALICYLIC ACID, 3% W/V
K842915 · E K Ind., Inc. · Aug 1984