Cleared Traditional

K920291 - MONI-TROL-L AND MONI-TROL-XL

K920291 is the FDA 510(k) clearance for MONI-TROL-L AND MONI-TROL-XL by Medical Analysis Systems, Inc.. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K920291 · Medical Analysis Systems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1992
Decision
224d
Days
Class 1
Risk

K920291 is an FDA 510(k) clearance for the MONI-TROL-L AND MONI-TROL-XL. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Medical Analysis Systems, Inc. (Camarillo, US). The FDA issued a Cleared decision on September 2, 1992 after a review of 224 days - an extended review cycle.

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 Medical Analysis Systems, Inc. devices

Submission Details

510(k) Number K920291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1992
Decision Date September 02, 1992
Days to Decision 224 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
136d slower than avg
Panel avg: 88d · This submission: 224d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 463
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K920291.
MULTIQUAL UNASSAYED PRODUCTS
K923632 · Ciba Corning Diagnostics Corp. · Oct 1992
MULTIQUAL ASSAY PRODUCTS
K923633 · Ciba Corning Diagnostics Corp. · Oct 1992
KODAK AMERLITE TOTAL THYROID CONTROL SERA
K923740 · Eastman Kodak Company · Sep 1992
AMERLITE FREE THYROID CONTROL SERA LAN.4002
K923165 · Eastman Kodak Company · Aug 1992
LYPHOCHEK UNASSAYED CHEMISTRY CONTROL LEVEL 3
K922046 · Bio-Rad · Jul 1992
DADE URINE CHEMISTRY CONTROL LEVELS I AND II
K920636 · Baxter Diagnostics, Inc. · Jul 1992