Cleared Traditional

K973898 - PROGESTERONE ELISA

K973898 is an FDA 510(k) clearance for PROGESTERONE ELISA, manufactured by Kmi Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code JLS cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K973898 · Kmi Diagnostics, Inc. · Chemistry device
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Nov 1997
Decision
30d
Days
Class 1
Risk

K973898 is an FDA 510(k) clearance for the PROGESTERONE ELISA. Classified as Radioimmunoassay, Progesterone (product code JLS), Class I - General Controls.

Submitted by Kmi Diagnostics, Inc. (Minneapolis, US). The FDA issued a Cleared decision on November 13, 1997 after a review of 30 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 Kmi Diagnostics, Inc. devices

FDA 510(k) Submission Details - K973898

510(k) Number K973898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1997
Decision Date November 13, 1997
Days to Decision 30 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 88d · This submission: 30d
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 K973898.
VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070)
K972133 · Johnson & Johnson Clinical Diagnostics, Inc. · Jun 1997
OPUS PROGESTERONE
K971725 · Behring Diagnostics, Inc. · Jun 1997
ELECSYS PROGESTERONE ASSAY
K964841 · Boehringer Mannheim Corp. · Mar 1997
VIDAS PROESTERONE (PRG) (30 409)
K965084 · bioMerieux, Inc. · Jan 1997
AXSYM PROGESTERONE
K955025 · Abbott Laboratories · Mar 1996
ACCESS PROGESTERONE ASSAY
K955769 · Bio-Rad Laboratories, Inc. · Feb 1996