Cleared Traditional

K933635 - STRATUS PROGESTERONE FLOUROMETRIC IMMUNOASSAY

K933635 is an FDA 510(k) clearance for STRATUS PROGESTERONE FLOUROMETRIC IMMUN..., manufactured by Baxter Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code JLS cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K933635 · Baxter Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1993
Decision
73d
Days
Class 1
Risk

K933635 is an FDA 510(k) clearance for the STRATUS PROGESTERONE FLOUROMETRIC IMMUNOASSAY. Classified as Radioimmunoassay, Progesterone (product code JLS), Class I - General Controls.

Submitted by Baxter Diagnostics, Inc. (Mcgaw Park, US). The FDA issued a Cleared decision on October 8, 1993 after a review of 73 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Baxter Diagnostics, Inc. devices

FDA 510(k) Submission Details - K933635

510(k) Number K933635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1993
Decision Date October 08, 1993
Days to Decision 73 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
15d faster than avg
Panel avg: 88d · This submission: 73d
Pathway characteristics
Predicate-based equivalence.

JLS Device Classification - Class 1, General Controls

Product Code JLS Radioimmunoassay, Progesterone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1620
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 - JLS Radioimmunoassay, Progesterone

All 40
Devices cleared under the same product code (JLS) and FDA review panel - the closest regulatory comparables to K933635.
SYNELISA PROGESTERONE
K933128 · Elias U.S.A., Inc. · Nov 1993
PROGESTERONE RADIOIMMUNOASSAY KIT
K931228 · Immunotech Corp. · Oct 1993
AIA-PACK(R) PROG ASSAY
K933269 · Tosoh Medics, Inc. · Oct 1993
CIBA CORNING ACS PROGESTERONE IMMUNOASSAY
K932955 · Ciba Corning Diagnostics Corp. · Aug 1993
FIAGEN PROGESTERONE
K923410 · Cyberfluor, Inc. · Dec 1992
AFFINITY PRG
K920230 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1992