Not Cleared Direct

DEN180004 - picoAMH ELISA

DEN180004 is an FDA 510(k) submission for picoAMH ELISA, manufactured by Ansh Labs, LLC. The device is a Class 2 Toxicology device with product code QDH cleared through the Direct 510(k) pathway after a 275-day FDA review.

DEN180004 · Ansh Labs, LLC · Toxicology device
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Oct 2018
Decision
275d
Days
Class 2
Risk

DEN180004 is an FDA 510(k) submission (not cleared) for the picoAMH ELISA. Classified as Menopause Test System (product code QDH), Class II - Special Controls.

Submitted by Ansh Labs, LLC (Webster, US). The FDA issued a Not Cleared (DENG) decision on October 24, 2018 after a review of 275 days.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1093 - the FDA toxicology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Incremental AI imaging tool. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Toxicology review framework.

FDA 510(k) Submission Details - DEN180004

510(k) Number DEN180004 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received January 22, 2018
Decision Date October 24, 2018
Days to Decision 275 days
Submission Type Direct
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
188d slower than avg
Panel avg: 87d · This submission: 275d
Pathway characteristics

QDH Device Classification - Class 2, Special Controls

Product Code QDH Menopause Test System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1093
Definition A Menopause Test System Is An In Vitro Diagnostic Device Intended To Measure Hormones Or Other Analytes In Human Clinical Specimens As An Aid In The Determination Of Menopausal Status In Women.
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 Toxicology devices follow this clearance model.

DEN180004 · picoAMH ELISA
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