510(k) Report

510(k) · Cleared

Cleared

Instaread Lithium System

K031579510(k) TraditionalCleared Dec 19, 2003213-day reviewClass II21 CFR 862.3560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Akers Laboratories, Inc. · JIH Flame Photometry, Lithium

Cleared on Dec 19, 2003 as substantially equivalent to K934106 (Eastman Kodak Company, 1994) after a 213-day review. Its family tree reaches back 1 generation to 1994.

Decided
Dec 19, 2003
Review
213 days
Class
Class II
Product code
JIH
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K934106 (1994). No later device cites it as a predicate yet.

K934106 · Kodak Ektachem DTSC II Slides (LI) · Eastman Kodak Company · 19941990199520002005
K934106 · Kodak Ektachem DTSC II Slides (LI) · Eastman Kodak Company · 19940
  1. Root · 1 generation backK934106 Kodak Ektachem DTSC II Slides (LI)Eastman Kodak Company · 1994
  2. This deviceK031579 Instaread Lithium SystemAkers Laboratories, Inc. · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K934106Kodak Ektachem DTSC II Slides (LI)Eastman Kodak Company1994—
0 (this device)K031579Instaread Lithium SystemAkers Laboratories, Inc.2003—
FIG. 1 — Lineage of K031579, 1994–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K934106Kodak Ektachem DTSC II Slides (LI)
Summary page 1
…InstaReadTM Lithium System is substantially equivalent to the Vitros Lithium System, Johnson & Johnson Clinical Diagnostics, Inc.- Rochester, NY K934106. 807.92 (a)(4): Device Description The InstaRead Tm Lithium System is an in vitro diagnostic device designed t…
Eastman Kodak Company1994—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.

How does its category compare?

All JIH devices

JIH Flame Photometry, Lithium: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JIH

FDA has decided no JIH device since 2007.

Median 510(k) review, days · JIH

Too few JIH 510(k)s in any year since 2007 to give a median.

Recalls per year · JIH

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JIH

5in 2025

2011: 12012: 22013: 22014: 12018: 22021: 12024: 12025: 5
2007high 5 (2025) · low 0 (2007)2025

MAUDE reports naming product code JIH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—01
20120—02
20130—12
20140—01
20150—00
20160—00
20170—00
20180—02
20190—00
20200—00
20210—01
20220—00
20230—00
20240—01
20250—05
20260—0—

What is it indicated for?

The InstaReadTM Lithium System is intended to measure lithium blood levels. Measurements of lithium are used to aid in the management of individuals taking lithium for the treatment of mental disturbances, such as manic-depressive illness (bipolar disorder). The test is targeted for physician's office use, and may be used with whole blood, serum, or EDTA-plasma.

Indications for use as stated in the FDA summary.

More from Akers Laboratories, Inc.

3 FDA decisions under this applicant name. See the company

  • K040293Healthtest Heparin/Platelet Factor 4 Antibody AssayAkers Laboratories, Inc. · 2004
  • K030815Akers Laboratories Inc. Blood Cell SeparatorAkers Laboratories, Inc. · 2003

Recent decisions in JIH

The JIH category page

  • K050338Modification to: Instaread Lithium SystemAkers Biosciences, Inc. · 2005
  • K011033Dimension Lithium (LI) Flex Reagent Cartridge, Model DF 132Dade Behring, Inc. · 2001
  • K934106Kodak Ektachem DTSC II Slides (LI)Eastman Kodak Company · 1994
  • K924488Kodak Ektachem Clinical Chemistry Slides (LI)Eastman Kodak Company · 19932 recalls
  • K921403Model 654 AnalyzerCiba Corning Diagnostics Corp. · 1992

https://510kreport.com/device/K031579 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031579: Instaread Lithium System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031579

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026