Cleared Traditional

K935219 - FERTILITY PLUS 1

K935219 is an FDA 510(k) clearance for FERTILITY PLUS 1, manufactured by Ciba Corning Diagnostics Corp.. The device is a Class 1 Chemistry device with product code JJY cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K935219 · Ciba Corning Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
147d
Days
Class 1
Risk

K935219 is an FDA 510(k) clearance for the FERTILITY PLUS 1, 2, 3. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Ciba Corning Diagnostics Corp. (Palo Alto, US). The FDA issued a Cleared decision on March 22, 1994 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 Ciba Corning Diagnostics Corp. devices

FDA 510(k) Submission Details - K935219

510(k) Number K935219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1993
Decision Date March 22, 1994
Days to Decision 147 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
59d slower than avg
Panel avg: 88d · This submission: 147d
Pathway characteristics
Predicate-based equivalence.

JJY Device Classification - Class 1, General Controls

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJY Multi-analyte Controls, All Kinds (assayed)

All 515
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K935219.
ACS CARDIO-TROL CONTROL
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K941912 · Behring Diagnostics, Inc. · Jun 1994
TMC I, II
K930534 · Ciba Corning Diagnostics Corp. · Apr 1994
ACS O DILVENT PROTEIN DILUTION MATRIX
K940397 · Analytical Control Systems, Inc. · Mar 1994
PARA 4 PLUS
K933844 · Streck Laboratories, Inc. · Dec 1993
DADE ANEMIA/HEMOCHROMATOSIS CONTOLS,LEVEL 1,LEVEL 2,AND LEVEL 3
K933437 · Baxter Diagnostics, Inc. · Oct 1993