Cleared Traditional

K971458 - ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT

K971458 is an FDA 510(k) clearance for ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ..., manufactured by Diagnostic Specialties. The device is a Class 1 Chemistry device with product code JIQ cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K971458 · Diagnostic Specialties · Chemistry device
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Sep 1997
Decision
133d
Days
Class 1
Risk

K971458 is an FDA 510(k) clearance for the ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT. Classified as Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.) (product code JIQ), Class I - General Controls.

Submitted by Diagnostic Specialties (Metuchen, US). The FDA issued a Cleared decision on September 2, 1997 after a review of 133 days - within the typical 510(k) review window.

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 Diagnostic Specialties devices

FDA 510(k) Submission Details - K971458

510(k) Number K971458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1997
Decision Date September 02, 1997
Days to Decision 133 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
45d slower than avg
Panel avg: 88d · This submission: 133d
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
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