(129 days)
Not Found
No
The description details a chemical assay based on precipitation and enzymatic reactions, with no mention of AI or ML technologies.
No.
This device is an in vitro diagnostic reagent used to quantify HDL-Cholesterol, which assists in diagnosis and risk assessment, rather than directly treating a condition.
Yes
The device "can assist in the diagnosis and treatment of patients at risk of developing coronary heart disease" by quantitatively determining High Density Lipoprotein Cholesterol. This falls under the definition of a diagnostic device as it provides information used for diagnosis.
No
The device is a reagent kit for in vitro diagnostic testing, which is a physical product, not 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 reagent is "intended for the in vitro quantitative determination of High Density Lipoprotein Cholesterol in human serum or plasma." The term "in vitro" is a key indicator of an IVD.
- Sample Type: The device analyzes "human serum or plasma," which are biological samples taken from the body for diagnostic purposes.
- Diagnostic Purpose: The intended use also states that the reagents "can assist in the diagnosis and treatment of patients at risk of developing coronary heart disease." This clearly indicates a diagnostic purpose.
- Device Description: The description details a chemical assay performed on the sample, which is typical of an IVD.
All these factors align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Diazyme HDL-Cholesterol reagent is intended for the in vitro quantitative determination of High Density Lipoprotein Cholesterol in human serum or plasma. The reagents can assist in the diagnosis and treatment of patients at risk of developing coronary heart disease. Low HDL cholesterol is related to the high risk of coronary heart disease.
For calibration of the Diazyme HDL-Cholesterol Reagent Assay in serum or plasma. For In Vitro Diagnostic Use.
To monitor the performance of Diazyme HDL-Cholesterol Reagent. For In Vitro Diagnostic Use.
Product codes (comma separated list FDA assigned to the subject device)
LBS, JIS
Device Description
The assay is based on a modified polyvinyl sulfonic acid (PVS) and polyethylene-glycol-methyl ether (PEGME) coupled classic precipitation method with the improvements in using optimized quantities of PVS/PEGME and selected detergents. LDL, VLDL, and chylomicron (CM) react with PVS and PEGME and the reaction results in inaccessibility of LDL, VLDL and CM by cholesterol oxidase (CHOD) and cholesterol esterase (CHER). The enzymes selectively react with HDL to produce H2O2 which is detected through a Trinder reaction.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Characteristics: Diazyme HDL-Cholesterol Reagent is a homogeneous two-reagent enzymatic assay. The results are obtained in 10 minutes by measuring absorbance at 600nm. The linearity of the assay is from 1.06-184.8 mg/dL for Serum samples. The assay offers excellent precision as shown in the tables below:
| Serum Testing | Level 1 30mg/dL HDL | Level 2 55mg/dL HDL | Level 3 90mg/dL HDL |
|---|---|---|---|
| Within-Run Precision | Cv% = 1.0% | Cv% = 0.8% | Cv% = 0.9% |
| Total Precision | Cv% = 2.3% | Cv% = 2.6% | Cv% = 2.2% |
In method comparison studies, samples tested with Diazyme HDL-Cholesterol Reagent showed good correlation with Genzyme Ultra N-geneous HDL Cholesterol Reagent (K021316) with correlation coefficients of 0.985 for serum samples.
Interference studies were conducted by spiking normal pooled human serum samples with substances normally present in serum or plasma and found no interference at the indicated concentrations.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Linearity: Serum: 1.06- 184.8 mg/dL
Precision/Serum: Within Run: 0.70% -1.10%, Total: 1.8%-3.7%
Accuracy/Serum: Correlation Coefficient: 0.987, Slope/Intercept: y = 1.048x - 4.69 mg/dL
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.
Not Found
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).
Not Found
§ 862.1475 Lipoprotein test system.
(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
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072395
JAN - 3 2008
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
| Submitter's name: | Diazyme Laboratories |
|---|---|
| Submitter's address: | 12889 Gregg Court |
| Poway, CA 92064 | |
| USA | |
| Name of Contact Person: | Charles Yu |
| Diazyme Laboratories | |
| 12889 Gregg Court | |
| Poway, CA 92064 | |
| Phone: 858-455-4761 | |
| Fax: 858-455-4750 | |
| Date the Summary was Prepared: | August 20, 2007 |
| Name of the Device | Diazyme HDL-Cholesterol Reagent |
| Trade Name: | Diazyme HDL-Cholesterol Reagent |
| Common/Usual Name | Lipoprotein Test System |
| Device Classification Name | High Density Lipoprotein Cholesterol Test |
| Product code: | LBS, JIS |
| Submission Type | 510k |
| Regulation Number | 862.1475 |
| Device Class | II |
| Predicate Device: | For the Lipoprotein test system, we are claiming equiva- |
| lence [807.92(a) (3) to HDL ULTRA CHOLESTEROL | |
| REAGENT (K021316) manufactured by Genzyme Diagnos- | |
| tics |
1
Substantial Equivalence Information
- l. Predicate device name(s):
Ultra N-Geneous HDL Cholesterol Reagent
2. Predicate 510(k) number(s):
3. Comparison with predicate:
Indications for Use
| Diazyme HDL-Cholesterol Reagent | Ultra N-geneous HDL Cholesterol Reagent | Equivalency |
|---|---|---|
| The Diazyme HDL-Cholesterol reagent is intended for the in vitro quantitative determination of High Density Lipoprotein Cholesterol in human serum or plasma. The reagents can assist in the diagnosis and treatment of patients at risk of developing coronary heart disease. Low HDL cholesterol is related to the high risk of coronary heart disease. | For the quantitative determination of high density lipoprotein cholesterol (HDL-C) in human serum or plasma. | Same |
Principle
| Diazyme HDL-Cholesterol Reagent | Ultra N-geneous HDL Cholesterol Reagent | Equivalency |
|---|---|---|
| The assay is based on a modified polyvinyl sulfonic acid (PVS) and polyethylene-glycol methyl ether (PEGME) coupled classic pre-cipitation method with the improvements in using optimized quantities of PVS/PEGME and selected detergents9. LDL, VLDL, and chylomicron (CM) react with PVS and PEGME and the reaction results in inaccessibility of LDL, VLDL and CM by cholesterol oxidase (CHOD) and cholesterol esterase (CHER). The enzymes selectively react with HDL to produce H2O2 which is detected through a Trinder reaction. | This method is based on accelerating the reaction of cholesterol oxidase(CO) with non-HDL unesterified cholesterol and dissolving HDL selectivity using a specific detergent. In the first reagent, non-HDL unesterified cholesterol is subject to an enzyme reaction, and the peroxide generated is consumed by a peroxidase reaction with DSBmT yielding a colorless product. The second reagent consists of a detergent capable of solubilizing HDL specifically , cholesterol esterase(CE) and chromagenic coupler to develop color for the quantitative determination of HDL-C. | Similar |
Test Objective
| Diazyme HDL-Cholesterol Reagent | Ultra N-geneous HDL Cholesterol Reagent | Equivalency |
|---|---|---|
| For the in vitro quantitative determination | ||
| of High Density Lipoprotein Cholesterol in | ||
| human serum or plasma. | For the quantitative determination of high | |
| density lipoprotein cholesterol (HDL-C) in | ||
| human serum or plasma. | Same | |
| Type of Test | ||
| Diazyme HDL-Cholesterol Reagent | Ultra N-geneous HDL Cholesterol Reagent |
Ultra N-geneous HDL Cholesterol Reagent Diazyme HDL-Cholesterol Reagent Equivalency Quantitative Quantitative Same
Specimen Type
2
| Diazyme HDL-Cholesterol Reagent | Ultra N-geneous HDL Cholesterol Reagent | Equivalency |
|---|---|---|
| Human serum or plasma | Human serum or plasma | Same |
Product Type
| Diazyme HDL-Cholesterol Reagent | Ultra N-geneous HDL Cholesterol Reagent | Equivalency |
|---|---|---|
| Calibrator, Reagent, Instrument | Calibrator, Reagent, Instrument | Same |
Performance
| Diazyme HDL-Cholesterol Reagent | Ultra N-geneous HDL Cholesterol Reagent |
|---|---|
| Reportable linear Range: | Reportable linear Range: |
| Serum: 1.06- 184.8 mg/dL | Serum: 2.5 - 200 mg/dL |
| Precision/Serum: | Precision/Serum: |
| Within Run: 0.70% -1.10% | Within Run: 0.5% -0.8% |
| Total: 1.8%-3.7% | Total: 1.1%-1.5% |
| Accuracy/Serum: | Accuracy/Serum: |
| Correlation Coefficient: 0.987 | Correlation Coefficient: 0.996 |
| Slope/Intercept: | Slope/Intercept: |
| y = 1.048x - 4.69 mg/dL | y = 0.99x + 2.81mg/dL |
Calibrator Comparison
| Diazyme HDL Cholesterol Calibrator | Ultra N-geneous HDL Cholesterol Calibrator | Equivalency |
|---|---|---|
| Lyophilized form | Lyophilized form | Same |
| HDL Cholesterol calibrator is traceable to NIST | ||
| SRM 1915b. | HDL Ultra Cholesterol calibrator is traceable | |
| to the National Reference System for | ||
| Cholesterol (NRS/CHOL) | Same |
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Rationale for Considering the Device Substantially Equivalent to Devices Approved for Interstate Commerce
Genzyme Ultra N-geneous HDL Cholesterol Reagent (K021316) was selected for comparing serum samples with to the results generated by Diazyme HDL-Cholesterol Reagent. Detailed performance characteristics and comparison analysis are given in this filing and demonstrate substantial equivalence to predicate device that is currently being legally marketed.
The Diazyme HDL-Cholesterol Reagent is similar to the approved predicate test. The minor differences in the performances of the tests should not affectiveness of the Diazyme HDL-Cholesterol Reagent and offers users a rapid device to measure HDL Cholesterol in human serum or plasma.
In summary, the dissimilar features between the Diazyme HDL-Cholesterol Reagent and device currently legally marketed do not affect the safety or effectiveness of the device. This is supported by the accuracy data comparing serum sample values obtained using the Diazyme HDL-Cholesterol Reagent with those obtained using the predicate device, Genzyme Ultra N-geneous HDL Cholesterol Reagent (K021316).
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Description of the Device
The assay is based on a modified polyvinyl sulfonic acid (PVS) and polyethylene-glycol-methyl ether (PEGME) coupled classic precipitation method with the improvements in using optimized quantities of PVS/PEGME and selected detergents. LDL, VLDL, and chylomicron (CM) react with PVS and PEGME and the reaction results in inaccessibility of LDL, VLDL and CM by cholesterol oxidase (CHOD) and cholesterol esterase (CHER). The enzymes selectively react with HDL to produce H2O2 which is detected through a Trinder reaction.
PVS HDL + LDL + VLDL + CM - PEGME --
HDL + (LDL + VLDL + VLDL + CM ) · PVS/PEGME
HDL + CHOD + CHER -> Fatty Acid + H2O2 Peroxidase 2H2O2 +4-AA+TODB -------------------------------------------------------------------------------------------------------------------------------------------------------------(Amax=560nm)
Intended Use of the Device:
The Diazyme HDL-Cholesterol reagent is intended for the in vitro quantitative determination of High Density Lipoprotein Cholesterol in human serum or plasma. The reagents can assist in the diagnosis and treatment of patients at risk for developing coronary heart disease. Low HDL cholesterol is related to the high risk of coronary heart disease.
Performance Characteristics
Diazyme HDL-Cholesterol Reagent is a homogeneous two-reagent enzymatic assay. The results are obtained in 10 minutes by measuring absorbance at 600nm. The linearity of the assay is from 1.06-184.8 mg/dL for Serum samples. The assay offers excellent precision as shown in the tables below:
| Serum Testing | Level 1
30mg/dL HDL | Level 2
55mg/dL HDL | Level 3
90mg/dL HDL |
|----------------------|------------------------|------------------------|------------------------|
| Within-Run Precision | $C_v% = 1.0%$ | $C_v% = 0.8%$ | $C_v% = 0.9%$ |
| Total Precision | $C_v% = 2.3%$ | $C_v% = 2.6%$ | $C_v% = 2.2%$ |
In method comparison studies, samples tested with Diazyme HDL-Cholesterol Reagent showed good correlation with Genzyme Ultra N-geneous HDL Cholesterol Reagent (K021316) with correlation coefficients of 0.985 for serum samples.
We have conducted interference studies by spiking normal pooled human serum samples with substances normally present in serum or plasma and found no interference at the indicated concentrations.
| Interference Study | |
|---|---|
| Substance | Concentration |
| Triglycerides | 1000 mg/dL |
| Ascorbic acid | 10 mmol/L |
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| Bilirubin | 40 mg/dL |
|---|---|
| Bilirubin Conjugated | 30 mg/dL |
| Hemoglobin | 1000 mg/dL |
Conclusion: Comparison analysis presented in this 510k submission filing in the comparison section, together with linearity, precision and interference and other detailed studies, demonstrates that the Diazyme HDL-Cholesterol Reagent has excellent accuracy and is safe and effective. There is no significant deviation between the results obtained by Diazyme HDL-Cholesterol Reagent and the legally marketed predicate device (K021316) when testing clinical patient samples and is therefore substantially similar. Comparison analysis presented in this 510k submission together with the stability data demonstrates that the Diazyme HDL-Cholesterol Reagent is substantially similar to legally marketed device (K021316).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three overlapping wings, representing the department's mission to protect the health of all Americans. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is simple and recognizable, conveying a sense of authority and trustworthiness.
Public Health Service
JAN - 3 2008
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Diazyme Laboratories c/o Mr. Charles Yu 12889 Gregg Court Poway, CA 92064
K072395 Re:
Trade/Device Name: Diazyme HDL-Cholesterol Reagent Regulation Number: 21 CFR8862.1475 Regulation Name: High Density Lipoprotein Cholesterol Test Regulatory Class: Class I Product Code: LBS, JJX Dated: December 21, 2007 Received: December 27, 2007
Dear Mr. Yu:
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 (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) 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 (240) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Yean M. Cooper, M.S., 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: | K072395 |
|---|---|
| Device Name: | Diazyme HDL-Cholesterol Reagent |
| Indications for Use: | The Diazyme HDL-Cholesterol reagent is intended for the in vitro |
| quantitative determination of High Density Lipoprotein Cholesterol in human | |
| serum or plasma. The reagents can assist in the diagnosis and treatment of | |
| patients at risk of developing coronary heart disease. | |
| Calibrator: | For calibration of the Diazyme HDL-Cholesterol Reagent Assay in |
| serum or plasma. | |
| For In Vitro Diagnostic Use | |
| Controls: | To monitor the performance of Diazyme HDL-Cholesterol Reagent. |
| For In Vitro Diagnostic Use |
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 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) and Sign-Oir
Office of In Vitro Diagnostic Device "Jation and Safety
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