Cleared Traditional

K002128 - ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100

K002128 is an FDA 510(k) clearance for ACTIVE INHIBIN-A ELISA, manufactured by Diagnostic Systems Laboratories, Inc.. The device is a Class 1 Chemistry device with product code NDR cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K002128 · Diagnostic Systems Laboratories, Inc. · Chemistry device
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Dec 2000
Decision
144d
Days
Class 1
Risk

K002128 is an FDA 510(k) clearance for the ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100. Classified as Enzyme Immunoassay, Inhibin-a (product code NDR), Class I - General Controls.

Submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on December 5, 2000 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1260 - 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 Systems Laboratories, Inc. devices

FDA 510(k) Submission Details - K002128

510(k) Number K002128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2000
Decision Date December 05, 2000
Days to Decision 144 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
56d slower than avg
Panel avg: 88d · This submission: 144d
Pathway characteristics
Predicate-based equivalence.

NDR Device Classification - Class 1, General Controls

Product Code NDR Enzyme Immunoassay, Inhibin-a
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1260
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.