Cleared Traditional

K103271 - MSC LIPID CONTROL

K103271 is an FDA 510(k) clearance for MSC LIPID CONTROL, manufactured by Maine Standards Co.. The device is a Class 1 Chemistry device with product code JJY cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K103271 · Maine Standards Co. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
81d
Days
Class 1
Risk

K103271 is an FDA 510(k) clearance for the MSC LIPID CONTROL. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Maine Standards Co. (Windham, US). The FDA issued a Cleared decision on January 25, 2011 after a review of 81 days - a notably fast clearance 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: 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 Maine Standards Co. devices

FDA 510(k) Submission Details - K103271

510(k) Number K103271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2010
Decision Date January 25, 2011
Days to Decision 81 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
7d faster than avg
Panel avg: 88d · This submission: 81d
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 593
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K103271.
VITAL SERUM CONTROLS
K111063 · Vital Diagnostics (Manufacturing) Ptyltd · Jun 2011
AUDIT MICROCV IMMUNOASSAY LINEARITY SET
K103601 · Aalto Scientific, Ltd. · Jun 2011
MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL
K103364 · Diamond Diagnostics, Inc. · May 2011
AUDIT MICROCV PROTEIN LINEARITY SET
K101216 · Aalto Scientific, Ltd. · Jan 2011
AUDIT MICROCV CARDIAC MARKERS LINEARITY SET
K102617 · Aalto Scientific, Ltd. · Jan 2011
FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20
K101809 · Fujirebio Diagnostics,Inc. · Oct 2010