Cleared Traditional

Proov Test (K191462) - FDA 510(k) Clearance

Class I Chemistry device.

K191462 · Mfb Fertility, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2020
Decision
269d
Days
Class 1
Risk

K191462 is an FDA 510(k) clearance for the Proov Test. Classified as Immunoassay, Pregnanediol Glucuronide, Over The Counter (product code QKE), Class I - General Controls.

Submitted by Mfb Fertility, Inc. (Erie, US). The FDA issued a Cleared decision on February 27, 2020 after a review of 269 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1620 - 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 Mfb Fertility, Inc. devices

Submission Details

510(k) Number K191462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2019
Decision Date February 27, 2020
Days to Decision 269 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
181d slower than avg
Panel avg: 88d · This submission: 269d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QKE Immunoassay, Pregnanediol Glucuronide, Over The Counter
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1620
Definition Over-the-counter Detection Of Pregnanediol Glucuronide For The Confirmation Of Ovulation
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 Consultant

Medical Device Academy, Inc.
Mary Vater

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.