(56 days)
Diazyme Sodium Enzymatic Assay Kit in conjunction with Diazyme Sodium Low and High Calibrators, are intended for the quantitative determination of sodium (NA) in serum.
Diazyme's Sodium Enzymatic assay is proven to be equivalent to ISE method but more user friendly in automated analyzers. Sodium is determined enzymatically via sodium dependent ß-galactosidase activity with ONPG as substrate. The absorbance at 405 nm of the product O-nitrophenyl is proportional to the sodium concentration.
Here's an analysis of the provided text regarding the Diazyme Sodium Enzymatic Assay, structured according to your request:
Acceptance Criteria and Study Details for Diazyme Sodium Enzymatic Assay
This submission focuses on establishing substantial equivalence to a predicate device rather than defining specific performance acceptance criteria against a clinical gold standard. The criteria are largely based on analytical performance compared to an established method.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Correlation with Predicate Method (ISE) | High correlation coefficient (e.g., >0.95 or similar to predicate) | 0.96 |
| Precision (CV%) | Low coefficient of variation (indicating reproducibility) | Within Precision: 144mM Na+: 3.2%; 164mM Na+: 3.0% |
| Total Precision: 144mM Na+: 5.3%; 164mM Na+: 3.3% | ||
| Analytical Recovery | Recoveries close to 100% (indicating accuracy) | 104% and 97% (for sodium added to two different sera) |
| Interference | Minimal or no significant interference from common substances | Little interference found at indicated concentrations for various substances (NH4Cl, NaPi, CaCl2, NaCl, etc.) |
| Measuring Range | Broad enough for clinical utility | 80 to 180 mmol/L |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states that the correlation study was performed with "clinical patient serum samples". However, it does not specify the exact sample size used for this comparison. The provenance of the data is not explicitly mentioned but is implied to be clinical samples relevant to sodium measurement. The study design is retrospective in the sense that it evaluates the performance of the new assay against an existing method on collected samples, but it doesn't specify if these were newly collected prospective samples or existing archived samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" for sodium concentration measurements in this context is the result obtained by a legally marketed and accepted method (Ion-Selective Electrode, ISE), not a subjective assessment by human experts.
4. Adjudication Method for the Test Set
Not applicable. There was no human adjudication process involved as the "ground truth" was established by a reference analytical method (ISE).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This submission is for an in-vitro diagnostic (IVD) assay that directly measures a biomarker (sodium concentration). It is not an AI-assisted diagnostic imaging or classification tool that would involve human readers or an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a "standalone" enzymatic assay in the sense that its results are generated by the chemical reaction and photometric measurement, not requiring direct human interpretation in the same way an imaging algorithm might. The performance described (precision, correlation, etc.) represents the intrinsic performance of the assay system.
7. The Type of Ground Truth Used
The ground truth used for comparison and validation was the results obtained from a legally marketed predicate device using the Ion-Selective Electrode (ISE) method. This represents a well-established and accepted analytical method for measuring sodium.
8. The Sample Size for the Training Set
Not applicable. This submission is for an enzymatic assay, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The assay's chemical and enzymatic principles are fixed, not learned from a large dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device. The assay development would have involved optimizing reaction conditions, reagent concentrations, and measurement parameters based on established biochemical principles and laboratory testing, not by training on a labeled dataset.
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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 composed of four diamond shapes arranged around a central point. The text is the main focus of the image, with the symbol serving as a visual element above it.
OCT 7 - 2004
Summary
Submitter's name:
Diazyme Laboratories Division, General Atomics
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
Date the summary was prepared:
August 6, 2004
| Name of the device: | Sodium Enzymatic Assay |
|---|---|
| Trade Name: | Diazyme Sodium Enzymatic Assay |
| Common/Usual Name: | Enzymatic Assay, Sodium |
| Classification Name: | Electrode, Ion Specific, Sodium |
| 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 sodium is regulated to maintain at 135-145mM. Small deviations from normal level can have severe health consequences. Monitoring serum sodium concentration is important in both routine check and emergency rooms. Currently, the two most commonly used methods to detect serum sodium are ion-selective electrode (ISE) and flame photometry. However, routine maintenance of these analyzers requires much effort and sometimes would be cumbersome. Diazyme's Sodium Enzymatic assay is proven to be equivalent to ISE method but more user friendly in automated analyzers.
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Sodium is determined enzymatically via sodium dependent ß-galactosidase activity with ONPG as substrate. The absorbance at 405 nm of the product O-nitrophenyl is proportional to the sodium concentration.
Nat → o-nitrophenol + galactose ONPG ß-galactosidase
ONPG = o-nitropheny1 -ß-D-galactopyranose
Intended Use of the Device:
Diazyme Sodium Enzymatic Assay Kit in conjunction with Diazyme Sodium Low and High Calibrators, are intended for the quantitative determination of sodium (NA) in serum.
Performance Characteristics
Diazyme's Sodium Enzymatic Assay is a two reagent (R1 and R2) based kinetic assay system. The results are obtained in 10 min by measuring absorbance at 405 nm. No off line pretreatment is needed. The assay has a wide measuring range from 80 to 180 mmol/L of serum sodium. The assay offers excellent precision as shown in the table below:
| 144mM Na+ | 164mM Na+ | |
|---|---|---|
| Within Precision | CV%=3.2% | CV%=3.0% |
| Total Precision | CV%=5.3% | CV%=3.3% |
Diazyme's Sodium Enzymatic assay has a good correlation with ISE method with a correlation coefficient of 0.96. The average analytical recoveries for sodium 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 |
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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 Sodium Enzymatic Assay has excellent accuracy and is safe and effective. There is no significant deviation between the results obtained by Diazyme's Sodium Enzymatic Assay and legally marketed predicate when testing clinical patient serum samples Therefore, Diazyme's Sodium Enzymatic Assay is substantially similar to the commercially available products to measure sodium levels in human serum samples.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread. The eagle is facing to the right and has three lines representing its wings.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 7 - 2004
Mr. Huan Tran Quality Assurance Manager Diazyme Laboratories 3550 General Atomics Court San Diego, CA 92121
K042189 Re: Trade/Device Name: Diazyme Sodium Enzymatic Assay Kit Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium test system Regulatory Class: Class II Product Code: MZU, JIT, 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 we have teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosale) to regars actment date of the Medical Device Amendments, or to conninered prior to May 20, 2017, in accordance with the provisions of the Federal Food, Drug, de vices that have been recuire approval of a premarket approval application (PMA). and Cosmetter recry. tee, the device, subject to the general controls provisions of the Act. The r ou may, therefore, mains of the Act include requirements for annual registration, listing of general controls profitering 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 your device to such additional controls. Existing major regulations affecting your device it may be subject to back 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 I hat FDA has made a determination that your device complies with other requirements of the Act that I Dr Has Intacted and regulations administered by other Federal agencies. You must or any I 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 (QS) 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) I his icter will anow you to ough finding of substantial equivalence of your device to a legally premaince houricated 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, If you destions on the promotion and advertising of your device, please contact the Office of of questions on the promote 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 I ou may oount one. Echerers, 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,
Sean M. Cooper US, DVM.
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
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Indications for Use
510(k) Number (if known): K042189
Device Name: Diazyme Sodium Enzymatic Assay Kit
Indications for Use:
Diazyme Sodium Enzymatic Assay Kit in conjunction with Diazyme Sodium Low Diazyme Coularn LEE are intended for the quantitative determination of sodium (NA) in serum.
Diazyme Sodium Enzymatic Assay Kit contains a low level standard and a high level standards The standards are used to generate a linear graph that will be iever bland and ulation of sodium concentrations in unknown serum samples.
Diazyme Sodium Enzymatic Assay has controls for normal serum sodium level and abnormal serum sodium level. The controls are used as reference samples for checking the functionality of the Diazyme Sodium 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 Cert
Division Sign-Off
Office of In Vitro Diagnostic
Device Evaluation and Safety
510(k) K042189
§ 862.1665 Sodium test system.
(a)
Identification. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.(b)
Classification. Class II.