510(k) Report

510(k) · Cleared

Cleared

Diazyme Lithium Enzymatic Assay Kit

K033360510(k) TraditionalCleared Dec 23, 200363-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

General Atomics · JII Atomic Absorption, Lithium

Cleared on Dec 23, 2003 as substantially equivalent to K003583 (Trace America, Inc., 2001) after a 63-day review. Its family tree reaches back 1 generation to 2001.

Decided
Dec 23, 2003
Review
63 days
Class
Class II
Product code
JII
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K003583 (2001). No later device cites it as a predicate yet.

K003583 · Lithium Regent Model TR66056 / Lithium Standard TR66901 · Trace America, Inc. · 2001200020022004
K003583 · Lithium Regent Model TR66056 / Lithium Standard TR66901 · Trace America, Inc. · 20010
  1. Root · 1 generation backK003583 Lithium Regent Model TR66056 / Lithium Standard TR66901Trace America, Inc. · 2001
  2. This deviceK033360 Diazyme Lithium Enzymatic Assay KitGeneral Atomics · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K003583Lithium Regent Model TR66056 / Lithium Standard TR66901Trace America, Inc.2001—
0 (this device)K033360Diazyme Lithium Enzymatic Assay KitGeneral Atomics2003—
FIG. 1 — Lineage of K033360, 2001–2003Source: 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.

Planning a device in JII? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • 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
*K003583Lithium Regent Model TR66056 / Lithium Standard TR66901
Summary page 1
…) Device Class: 11 Predicate Device: The legally marketed device to which we are claiming equivalence [807.92(a)(3)]: Trace Lithium Reagent (K003583) manufactured by Trace America, Inc., Arlington, Texas. Description of the devices Currently, the most commonly used meth…
Trace America, Inc.2001—

Also cleared against K003583: 2 other devices →

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.
  • 2 other devices also cite its predicate K003583.

How does its category compare?

All JII devices

JII Atomic Absorption, Lithium: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JII

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JII

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

Recalls per year · JII

No recall names JII since 2007.

Adverse event reports per year · JII

No MAUDE report names JII since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20081—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

Diazyme Lithium Enzymatic Assay Kit is for quantitative in vitro determination of

lithium in human serum. Measurements of lithium are carried out essentially to ensure

that proper drug dosage is administered in the treatment of patient suffering from bipolar

disorder and to avoid toxicity.

Indications for use as stated in the FDA summary.

Also cleared against K003583

2 other devices cite the same predicate.

  • K063705Lithium Micro Volume Electrode, Theophylline, Ise Calibrators 1, 2 and 3, TDM Calibration Set B, Nortrol and…Thermo Electron OY · 2007
  • K070987Sentinel Lithium AssaySENTINEL CH. SpA · 20072 recalls

More from General Atomics

6 FDA decisions under this applicant name. See the company

  • K082488Diazyme LP (a) AssayGeneral Atomics · 2009
  • K072977Diazyme Apolipoprotein a-1 AssayGeneral Atomics · 2008
  • K072523Diazyme LDL-Cholesterol Reagent, Calibrator and ControlsGeneral Atomics · 2008
  • K050178HBA1C Enzymatic AssayGeneral Atomics · 2005
  • K042448Diazyme Homocysteine Enzymatic Assay KitGeneral Atomics · 2004

Recent decisions in JII

The JII category page

  • K082001Diazyme Liquid Stable Enzymatic Lithium Assay, Model DZ116BDiazyme Laboratories · 2008
  • K912244Urotest GPHIn Wha Pharmaceutical Co., Ltd. · 1991

https://510kreport.com/device/K033360 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033360: Diazyme Lithium Enzymatic Assay Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033360

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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