(78 days)
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No
The device description details a standard enzymatic assay with spectrophotometric detection. There is no mention of AI/ML algorithms for data analysis, interpretation, or decision-making. The performance studies focus on correlation with a predicate device and analytical recovery, not on the performance metrics typically associated with AI/ML models (e.g., AUC, sensitivity, specificity).
No
The device is an in vitro diagnostic assay intended for the quantitative determination of potassium in serum, which is used for diagnosis, not treatment.
Yes
The device is intended for the quantitative determination of Potassium (K) in serum, which is used to diagnose conditions related to potassium levels.
No
The device description clearly outlines a chemical assay kit involving reagents and spectrophotometric measurement, indicating a hardware-based laboratory test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of Potassium (K) in serum." This is a measurement performed on a biological sample (serum) outside of the body to provide information about a patient's health status.
- Device Description: The description details a "spectrophotometric through a kinetic coupling assay system" that measures a substance (Potassium) in a biological sample (serum) using chemical reagents. This is a typical description of an in vitro diagnostic test.
- Performance Studies: The performance studies describe correlation with a "Clinical System" and analytical recoveries, which are standard evaluations for IVD devices.
- Predicate Device: The mention of a "Predicate Device" (Synchron LX I 725 Clinical System) which is a clinical laboratory analyzer, further confirms its nature as an IVD.
All these elements align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Diazyme Potassium Enzymatic Assay Kit in conjunction with Diazyme Potassium Low and High Calibrators, are intended for the quantitative determination of Potassium (K) in serum.
Diazyme Potassium Enzymatic Assay Kit contains a low level standard and a high level standard. The standards are used to generate a linear graph that will be used in the calculation of potassium concentrations in unknown serum samples.
Diazyme Potassium Enzymatic Assay has controls for normal serum potassium level and abnormal serum potassium level. The controls are used as reference samples for checking the functionality of the Diazyme Potassium Enzymatic Assay.
Product codes (comma separated list FDA assigned to the subject device)
MZV, JJX
Device Description
In healthy individual, an extracellular fluid level of potassium is regulated to maintain at 3.5-5.5mM. Small deviations from normal level can have severe health consequences. Monitoring serum potassium concentration is important in both routine check and emergency rooms. Currently, the two most commonly used methods to detect serum potassium are ion-selective electrode (ISE) and flame photometry. However, routine maintenance of these analyzers requires much effort and sometimes would be cumbersome. Diazyme's Potassium Enzymatic assay is proven to be equivalent to ISE method but more user friendly in automated analyzers.
Potassium is determined spectrophotometrically through a kinetic coupling assay system using potassium dependent urea amidolyase (UAL). NADH generated in a coupling enzymatic reaction reduces a water soluble colorless tetrazolium salt, WST-1 in the presence of an electron mediator, 1-methoxy-5-methyl-phenazinium methyl sulfate (PMS), to form a water soluble formazan dye, which has a maximum absorbance at 450 nm. The corresponding increase of optical density at 450 nm is proportional to the potassium concentration in the serum.
Diazyme's Potassium Enzymatic Assay is a two reagent (R1 and R2) based kinetic assay system. The results are obtained in 15 min by measuring absorbance at 450 nm. No off line pretreatment is needed. The assay has a wide measuring range from 2 to 8 mmol/L of serum potassium.
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
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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)
Performance studies included precision, correlation with a predicate device, and interference studies.
Precision:
| Precision | |
|---|---|
| 013 Precision | ALL PRODUCT CALL CON L. CAR L. C. Market Counce Callery College ANNUAL A AND A C - C - C - C - C - C - C - C - C - C - C - C - C - C - C - C - C - C - C - C - C - C - C - C - C - C - C - C - - - - - - - - - - - - - - - - - - - - - - - |
Correlation with predicate: Diazyme's Potassium Enzymatic assay has a good correlation with Synchron LX 1 725 Clinical System with a correlation coefficient of 0.96.
Analytical recoveries for potassium added to two different sera were 104% and 97% respectively.
Interference study was conducted by spiking substances to pooled human sera; little interference was found at indicated concentrations.
Key results: The Diazyme's Potassium Enzymatic Assay has excellent accuracy and is safe and effective. There is no significant deviation between the results obtained by Diazyme's Potassium Enzymatic Assay and legally marketed predicate when testing clinical patient serum samples.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation coefficient: 0.96
Analytical recoveries: 104% and 97%
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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§ 862.1600 Potassium test system.
(a)
Identification. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.(b)
Classification. Class II.
0
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 symbol. The symbol is black and has a slightly gothic appearance. The overall image is simple and clear, with a focus on the text and the symbol.
OCT 2 9 2004
Summary
Submitter's name:
Submitter's address:
Phone: Fax: Name of Contact Person: 3550 General Atomics Court San Diego, CA 92121 858-455-4761 858-455-4750 Huan Tran Diazyme Laboratories Division General Atomics 3550 General Atomics Court San Diego. CA 92121 Phone: 858-455-4761 Fax: 858-455-4750
Diazyme Laboratories Division, General Atomics
Date the summarv was prepared: August 9, 2004
| Name of the device: | Potassium Enzymatic Assay |
|---|---|
| Trade Name: | Diazyme Potassium Enzymatic Assay |
| Common/Usual Name: | Enzymatic Assay, Potassium |
| Classification Name: | Electrode, Ion Specific, Potassium |
| Device Class: | II |
Predicate Device:
The legally marketed device to which we are claiming equivalence [807.92(a)(3)]: Synchron LX I 725 Clinical System (K023049) manufactured by Beckman Coulter Inc., Brea, CA, USA.
Description of the devices
In healthy individual, an extracellular fluid level of potassium is regulated to maintain at 3.5-5.5mM. Small deviations from normal level can have severe health consequences. Monitoring serum potassium concentration is important in both routine check and emergency rooms. Currently, the two most commonly used methods to detect serum potassium are ion-selective electrode (ISE) and flame photometry. However, routine maintenance of these analyzers requires much effort and sometimes would be cumbersome. Diazyme's Potassium Enzymatic assay is proven to be equivalent to ISE method but more user friendly in automated analyzers.
Potassium is determined spectrophotometrically through a kinetic coupling assay system using potassium dependent urea amidolyase (UAL). NADH generated in a coupling enzymatic reaction reduces a water soluble colorless tetrazolium salt, WST-1 in the presence of an electron
1
mediator, 1-methoxy-5-methyl-phenazinium methyl sulfate (PMS), to form a water soluble formazan dye, which has a maximum absorbance at 450 nm. The corresponding increase of optical density at 450 nm is proportional to the potassium concentration in the serum
Intended Use of the Device:
Diazyme Potassium Enzymatic Assay Kit in conjunction with Diazyme Potassium Low and High Calibrators, are intended for the quantitative determination of Potassium (K) in serum.
Performance Characteristics
Diazyme's Potassium Enzymatic Assay is a two reagent (R1 and R2) based kinetic assay system. The results are obtained in 15 min by measuring absorbance at 450 nm. No off line pretreatment is needed. The assay has a wide measuring range from 2 to 8 mmol/L of serum potassium. The assay offers excellent precision as shown in the table below:
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Acres of the count
1 | Canadian Co., Annual
A Book Company of Children Company of |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| recision
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | A BORD C LEBELL LE &
STATUTE OF COLUMNATION | |
| 013
Precision | ALL PRODUCT CALL CON L. CAR L. C.
Market Counce
Callery College
ANNUAL A AND A C - C - C - C - C - C - C - C - C - C - C - C - C - C - C - C - C - C - C - C - C - C - C - C - C - C - C - C - C - - - - - - - - - - - - - - - - - - - - - - - | ANNUAL AND PRODUCT CARDER & A CLAIM A COLOR COLLEGIAL CONSULTION OF COLLECTION CONSULTION OF |
Diazyme's Potassium Enzymatic assay has a good correlation with Synchron LX 1 725 Clinical System with a correlation coefficient of 0.96. The average analytical recoveries for potassium added to two different sera were 104% and 97% respectively. 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 | 1 mM |
| NaPi | 1.5 mM |
| CaCl2 | 5 mM |
| NaCl | 200 mM |
| CuCl2 | 0.25 mM |
| ZnCl2 | 0.25 mM |
| FeCl3 | 0.025 mM |
| Ascorbic Acid | 5 mM |
| Glucose | 5 mM |
| Bilirubin | 10mg/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 Potassium Enzymatic Assay has excellent accuracy and is safe and effective. There is no significant deviation between the results obtained by Diazyme's Potassium Enzymatic Assay and legally marketed predicate when testing clinical patient serum
2
samples Therefore, Diazyme's Potassium Enzymatic Assay is substantially similar to the commercially available products to measure potassium levels in human serum samples.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The caduceus is composed of three curved lines that resemble a stylized staff with snakes intertwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus symbol.
OCT 2 9 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Huan Tran Quality Assurance Manager Diazyme Laboratories Division of General Atomics 3550 General Atomics Court San Diego, CA 92121
K042191 Re:
Trade/Device Name: Diazyme Potassium Enzymatic Assay Kit Diazyme Enzymatic Potassium Serum Controls Regulation Number: 21 CFR 862.1600 Regulation Name: Potassium test system Regulatory Class: Class II Product Code: MZV, JJX Dated: August 9, 2004 Received: August 12, 2004
Dear Mr. Tran:
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
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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). You may obtain other general information on your responsibilities under the Act 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,
Jean M. Cooper, US, Div.
Jean M. Cooper, MS. D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K042191
Device Name: Diazyme Potassium Enzymatic Assay Kit
Indications for Use:
Diazyme Potassium Enzymatic Assay Kit in conjunction with Diazyme Potassium Low and High Calibrators, are intended for the quantitative determination of sodium (K) in serum.
Diazyme Potassium Enzymatic Assay Kit contains a low level standard and a high level standard. The standards are used to generate a linear graph that will be used in the calculation of potassium concentrations in unknown serum samples.
Diazyme Potassium Enzymatic Assay has controls for normal serum potassium level and abnormal serum potassium level. The controls are used as reference samples for checking the functionality of the Diazyme Potassium Enzymatic Assay.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Albert Cuti'
Division Sign-Off
Office of In Vitro Diagnostic
510(k) K042191