Cleared Special

K050338 - MODIFICATION TO: INSTAREAD LITHIUM SYSTEM

K050338 is an FDA 510(k) clearance for MODIFICATION TO: INSTAREAD LITHIUM SYSTEM, manufactured by Akers Biosciences, Inc.. The device is a Class 2 Chemistry device with product code JIH cleared through the Special 510(k) pathway after a 21-day FDA review.

K050338 · Akers Biosciences, Inc. · Chemistry device
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Mar 2005
Decision
21d
Days
Class 2
Risk

K050338 is an FDA 510(k) clearance for the MODIFICATION TO: INSTAREAD LITHIUM SYSTEM. Classified as Flame Photometry, Lithium (product code JIH), Class II - Special Controls.

Submitted by Akers Biosciences, Inc. (Thorofare, US). The FDA issued a Cleared decision on March 4, 2005 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3560 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K050338

510(k) Number K050338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2005
Decision Date March 04, 2005
Days to Decision 21 days
Submission Type Special
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
68d faster than avg
Panel avg: 89d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

JIH Device Classification - Class 2, Special Controls

Product Code JIH Flame Photometry, Lithium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3560
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JIH Flame Photometry, Lithium

All 11
Devices cleared under the same product code (JIH) and FDA review panel - the closest regulatory comparables to K050338.
INSTAREAD LITHIUM SYSTEM
K031579 · Akers Laboratories, Inc. · Dec 2003
DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132
K011033 · Dade Behring, Inc. · Jun 2001
KODAK EKTACHEM DTSC II SLIDES (LI)
K934106 · Eastman Kodak Company · Apr 1994
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LI)
K924488 · Eastman Kodak Company · Jan 1993
MODEL 654 ANALYZER
K921403 · Ciba Corning Diagnostics Corp. · Jul 1992
AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE
K895465 · Baxter Healthcare Corp · Dec 1989
K050338 · MODIFICATION TO: INSTAREAD LITHIUM SYSTEM
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