(63 days)
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No
The device description details a spectrophotometric enzymatic assay, which is a traditional chemical analysis method. There is no mention of AI, ML, or any computational learning processes in the provided text.
No
The Diazyme Lithium Enzymatic Assay Kit is an in vitro diagnostic device used to measure lithium levels in human samples, which aids in monitoring drug dosage and preventing toxicity, but it does not directly treat or prevent a disease.
Yes
Explanation: The device is used for quantitative in vitro determination of lithium in human serum and plasma to monitor drug dosage and avoid toxicity in patients with bipolar disorder, which is a diagnostic purpose.
No
The device description clearly outlines a spectrophotometric enzymatic assay kit, which is a chemical reagent-based system requiring a clinical chemistry analyzer (hardware) to function. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the kit is "for quantitative in vitro determination of lithium in human serum and plasma." The phrase "in vitro" is a key indicator of an IVD.
- Device Description: The description details a "spectrophotometric method" that analyzes "human serum and plasma." This involves testing biological samples outside of the body, which is the definition of an in vitro diagnostic.
- Purpose: The intended use also mentions that the measurements are "carried out essentially to ensure that proper drug dosage is administered... and to avoid toxicity." This indicates the device is used to provide information for medical diagnosis or treatment, a core function of IVDs.
N/A
Intended Use / Indications for Use
Diazyme Lithium Enzymatic Assay Kit is for quantitative in vitro determination of lithium in human serum and plasma. 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.
Product codes (comma separated list FDA assigned to the subject device)
JII
Device Description
Currently, the most commonly used methods to detect serum lithium are ion-selective electrode (ISE) atomic absorption spectrophotometry, and flame emission photometry. However, routine maintenance of these analyzers requires much effort and sometimes can be cumbersome. Diazyme's lithium enzymatic assay is a spectrophotometric method, which can be adapted to most automated clinical chemistry analyzers.
In Diazyme's lithium enzymatic assay, Lithium is determined spectrophotometrically through a kinetic coupling assay system involving a Diazyme's proprietary phosphatase whose activity is sensitive to lithium concentration (IC50=0.1mM). Through enzymatic coupling, the phosphatase substrate, adenosine biphosphate (PAP) is converted to hypoxanthine by a series of enzymatic reactions to generate uric acid and hydrogen peroxide (H2O2). H2O2 generated reacts with N-Ethyl-N-(2-hydroxy-3-sulfopropyl)-3-m-toluidine (EHSPT) and 4-aminoantipyrine (4-AA) in the presence of peroxidase (POD) to form a quinone dye which has maximal absorbance at 556nm. The rate of the quinine dye formation is inversely proportion to the concentration of lithium in serum samples.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
human serum and plasma
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison analysis presented in the 510K submission for this device in the comparison section, together with linearity, precision and interference study presented demonstrated that the Diazyme's Lithium Enzymatic assay has excellent accuracy and is safe and effective. There is no significant deviation between the results obtained by Diazyme's Lithium Enzymatic assay and legally marketed predicate Trace Lithium Reagent when testing clinical patient serum samples.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The assay has a wide measuring range from 0 to 3 mmol/L.
Within Precision: (1.0mM Li+) CV%=4.7%, (2.4mM Li+) CV%=3.3%
Total Precision: (1.0mM Li+) CV%=6.9%, (2.4mM Li+) CV%=5.5%
Correlation coefficient of 0.97 with both Trace colorimetric method and ISE method.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 862.3560 Lithium test system.
(a)
Identification. A lithium test system is a device intended to measure lithium (from the drug lithium carbonate) in serum or plasma. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).(b)
Classification. Class II.
0
K03360
Image /page/0/Picture/2 description: The image shows the word "DIAZYME" in bold, block letters. Above the word is a four-pointed star-like shape, with each point resembling a diamond. The text and the star are both in black, contrasting with the white background.
Submitter's name:
Summary
Diazyme Laboratories Division, General Atomics
3550 General Atomics Court Submitter's address: San Diego, CA 92121 858-455-4754 Phone: 858-455-4760 Fax: Chong Yuan, Ph.D. Name of Contact Person: Diazyme Laboratories Division General Atomics 3550 General Atomics Court San Diego, CA 92121 Phone: 858-455-4754
October 16, 2003 Date the summary was prepared:
| Name of the device: | Lithium Enzymatic Assay |
|---|---|
| Trade Name: | Diazyme Lithium Enzymatic Assay |
| Common/Usual Name: | Enzymatic Assay, Lithium |
| Classification Name: | Single (Specified) Analyte Controls (Per 21CFR section 862.1660) |
| Device Class: | II |
Fax: 858-455-4760
Predicate Device:
The legally marketed device to which we are claiming equivalence [807.92(a)(3)]: Trace Lithjum Reagent (K003583) manufactured by Trace America, Inc., Arlington, Texas.
Description of the devices
Currently, the most commonly used methods to detect serum lithium are ion-selective electrode (ISE) atomic absorption spectrophotometry, and flame emission photometry. However, routine maintenance of these analyzers requires much effort and sometimes can be cumbersome. Diazyme's lithium enzymatic assay is a spectrophotometric method, which can be adapted to most automated clinical chemistry analyzers.
In Diazyme's lithium enzymatic assay, Lithium is determined spectrophotometrically through a kinetic coupling assay system involving a Diazyme's proprietary phosphatase whose activity is sensitive to lithium concentration (IC50=0.1mM). Through enzymatic coupling, the phosphatase substrate, adenosine biphosphate (PAP) is converted to hypoxanthine by a series of enzymatic reactions to generate uric acid and hydrogen peroxide (H2O2). H2O2 generated reacts with N-Ethyl-N-(2-hydroxy-3-sulfopropyl)-3-m-toluidine (EHSPT) and 4-aminoantipyrine (4-AA) in the
1
presence of peroxidase (POD) to form a quinone dye which has maximal absorbance at 556nm. The rate of the quinine dye formation is inversely proportion to the concentration of lithium in serum samples.
Intended Use of the Device:
Diazyme Lithium Enzymatic Assay Kit is for quantitative in vitro determination of lithium in human serum and plasma. 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.
Performance Characteristics
Diazyme's lithium enzymatic assay is a two reagent (R1 and R2) based kinetic assay system. The results are obtained in 10 min by measuring absorbance at 550 nm. No off line pretreatment is needed. The assay has a wide measuring range from 0 to 3 mmol/L. The assay offers excellent precision as shown in the table below:
| 1.0mM Li+ | 2.4mM Li+ | |
|---|---|---|
| Within Precision | CV%=4.7% | CV%=3.3% |
| Total Precision | CV%=6.9% | CV%=5.5% |
Diazyme's Lithium Enzymatic assay has good correlation with both Trace colorimetric method and ISE method (correlation coefficient of 0.97 for both methods). We have conducted interference study by spiking the substances to be tested to the pooled human sera and found little interference at the indicated concentrations
| Interference | Concentration |
|---|---|
| NH4Cl | 0.5 mM |
| KPi | 1.5 mM |
| CaCl2 | 5 mM |
| NaCl | 200 mM |
| KCl | 10mM |
| CuCl2 | 0.25 mM |
| FeCl3 | 0.25mM |
| ZnCl2 | 0.25 mM |
| Triglyceride | 250mg/dl |
| Ascorbic Acid | 5 mM |
| Bilirubin | 45 mg/dl |
Conclusion: Comparison analysis presented in the 510K submission for this device in the comparison section, together with linearity, precision and interference study presented demonstrated that the Diazyme's Lithium Enzymatic assay has excellent accuracy and is safe and effective. There is no significant deviation between the results obtained by Diazyme's Lithium Enzymatic assay and legally marketed predicate Trace Lithium Reagent when testing clinical patient serum samples. Therefore, Diazyme's Lithium Enzymatic assay is substantially
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similar to the commercially available products to measure lithium levels in human serum samples.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. Above the caduceus, there are three parallel lines that curve upwards, resembling the wings of a bird. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 3 2003
Chong Yuan, Ph.D. Managing Director General Atomics Diazyme Laboratories 3550 General Atomics Court San Diego, CA 92121-1194
K033360 Re:
Trade/Device Name: Diazyme Lithium Enzymatic Assay Kit Regulation Number: 21 CFR 862.3560 Regulation Name: Lithium test system Regulatory Class: Class II Product Code: JII Dated: October 16, 2003 Received: October 29, 2003
Dear Dr. Yuan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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FDA INDICATIONS FOR USE FORM
510(k) Number (if known): K033360____________________________________________________________________________________________________________________________________________
Device Name: Diazyme Lithium Enzymatic Assay Kit
Indications for Use:
Diazyme Lithium Enzymatic Assay Kit is for quantitative in vitro determination of Diazyme Dithium Entzyments 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
| Division Sign-Off | Carol Benson |
|---|---|
| (Optional Format 1-2-96) |
Office of In Vitro Diagnostic Device
Evaluation and Safety
| 510(k) | K033360 |
|---|---|
| -------- | --------- |