Cleared Traditional

K031579 - INSTAREAD LITHIUM SYSTEM

K031579 is an FDA 510(k) clearance for INSTAREAD LITHIUM SYSTEM, manufactured by Akers Laboratories, Inc.. The device is a Class 2 Toxicology device with product code JIH cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K031579 · Akers Laboratories, Inc. · Toxicology device
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Optimized for regulatory review, auditing and printing
Dec 2003
Decision
213d
Days
Class 2
Risk

K031579 is an FDA 510(k) clearance for the INSTAREAD LITHIUM SYSTEM. Classified as Flame Photometry, Lithium (product code JIH), Class II - Special Controls.

Submitted by Akers Laboratories, Inc. (Thorofare, US). The FDA issued a Cleared decision on December 19, 2003 after a review of 213 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3560 - the FDA toxicology device 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Akers Laboratories, Inc. devices

FDA 510(k) Submission Details - K031579

510(k) Number K031579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2003
Decision Date December 19, 2003
Days to Decision 213 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 87d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Toxicology 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 K031579.
MODIFICATION TO: INSTAREAD LITHIUM SYSTEM
K050338 · Akers Biosciences, Inc. · Mar 2005
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