(137 days)
No
The description details a chemical assay based on enzymatic reactions and spectrophotometry, with no mention of AI or ML algorithms for data analysis or interpretation.
No
Explanation: This device is an in vitro diagnostic assay used to quantify LDL-Cholesterol. While the results can assist in diagnosis and treatment strategies, the device itself does not directly treat or prevent a disease. It provides information for diagnostic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states that the reagents "can assist in the diagnosis and treatment of patients at risk of developing coronary heart disease." This directly indicates a diagnostic purpose.
No
The device description clearly outlines a chemical assay involving reagents and enzymatic reactions, which are physical components and processes, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Diazyme LDL-Cholesterol Assay is intended for the in vitro quantitative determination of Low Density Lipoprotein Cholesterol in human serum or plasma."
The term "in vitro" means "in glass" or "in the laboratory," referring to tests performed outside of the living body. The purpose of the assay is to measure a substance (LDL Cholesterol) in a biological sample (human serum or plasma) to assist in diagnosis and treatment. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Diazyme LDL-Cholesterol Assay is intended for the in vitro quantitative determination of Low 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. Elevated LDL cholesterol is the primary target of cholesterol-lowering therapy.
Product codes
LBR, JIS, JIX
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), whereas HDL reacts with the enzymes. Addition of R2 containing a specific detergent releases LDL from the PVS/PEGME complex. The released LDL reacts with the enzymes to produce H2O2 which is quantified by the 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
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Summary of Performance Studies
The Diazyme LDL-Cholesterol Reagent is a homogeneous two-reagent enzymatic assay. The results are obtained in 10 minutes by measuring absorbance at 600 nm. The linearity of the assay is from 1.64 -830 mg/dL for serum samples. The assay offers excellent precision as shown in the tables below:
| Serum Testing | Level 1
95mg/dL LDL | Level 2
146mg/dL LDL | Level 3
210mg/dL LDL |
|---|---|---|---|
| Within-Run Precision | Cv % = 1.0% | Cv % = 0.8% | Cv % = 0.7% |
| Total Precision | Cv % = 1.6% | Cv % = 1.5% | Cv % = 1.4% |
In method comparison studies, samples tested with Diazyme LDL-Cholesterol Reagent showed good correlation with Genzyme N-geneous LDL Cholesterol Reagent (K971573) with correlation coefficients of 0.996 for serum samples.
Interference studies were conducted by spiking normal pooled human serum samples with substances normally present in serum or plasma and found less than 10% interference at the indicated concentrations.
| Interference Study | |
|---|---|
| Substance | Concentration |
| Triglycerides | 1000 mg/dL |
| Ascorbic acid | 10 mmol/L |
| Bilirubin | 40 mg/dL |
| Bilirubin Conjugated | 40 mg/dL |
| Hemoglobin | 1000 mg/dL |
Key Metrics
Reportable Range:
Serum: 2.04 - 250 mg/dL
Precision/Serum:
Within Run: 0.7% -1.0%
Total: 1.4%-1.6%
Accuracy/Serum:
Correlation Coefficient: 0.9804
Slope/Intercept: y = 1.0883x + 0.6078 mg/dL
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
K072523
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 22, 2007 |
| Name of the Device | Diazyme LDL-Cholesterol Reagent |
| Trade Name: | Diazyme LDL-Cholesterol Reagent |
| Common/Usual Name | Lipoprotein Test System |
| Device Classification Name | Low Density Lipoprotein Cholesterol Reagent |
| Product code: | LBR, JIS, JIX |
| 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 N-GENEOUS LDL CHOLES | |
| TEROL REAGENT (K971573) manufactured by Genzyme | |
| Diagnostics |
:
1
Substantial Equivalence Information
1. Predicate device name(s):
Genzyme N-Geneous LDL Cholesterol Reagent
2. Predicate 510(k) number(s):
3. Comparison with predicate:
Indications for Use
| Diazyme LDL-Cholesterol Reagent | Genzyme N-Geneous LDL Cholesterol
Reagent | Equivalency |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| The Diazyme LDL-Cholesterol Assay is
intended for the in vitro quantitative
determination of Low 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. Elevated LDL
cholesterol is the primary target of
cholesterol-lowering therapy. | For the direct, quantitative measurement of
low density lipoprotein cholesterol (LDL-
C) concentration in human serum or
plasma. | Same |
Principle
| Diazyme LDL-Cholesterol Reagent | Genzyme N-Geneous LDL 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 detergents. LDL, VLDL, and
chylomicron (CM) react with PVS and
PEGME and the reaction results in inaccessi-
bility 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 in a two reagent format and
depends on the properties of a unique de-
tergent. This detergent ( Reagent 1) solubi-
lizes only the non LDL lipoprotein parti-
cles. The cholesterol released is consumed
by cholesterol esterase and cholesterol oxi-
dase in a non color forming reaction. A
second detergent (Reagent 2) solubilizes
the remaining LDL particles and a chro-
mogenic coupler allows for color forma-
tion. The enzyme reaction with LDL-C in
the presence of the coupler produces color
that is proportional to the amount of LDL
cholesterol present in the sample. | Similar |
Test Objective
| Diazyme LDL-Cholesterol Reagent | Genzyme N-Geneous LDL Cholesterol
Reagent | Equivalency |
|--------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| For the in vitro quantitative determination
of low density lipoprotein cholesterol in
human serum or plasma. | For the direct, quantitative measurement of
low density lipoprotein cholesterol (LDL-
C) concentration in human serum or
plasma. | Same |
2
Type of Test
| Diazyme LDL-Cholesterol Reagent | Genzyme N-Geneous LDL Cholesterol
Reagent | Equivalency |
|---------------------------------|----------------------------------------------|-------------|
| Quantitative | Quantitative | Same |
Specimen Type
| Diazyme LDL-Cholesterol Reagent | Genzyme N-Geneous LDL Cholesterol
Reagent | Equivalency |
|---------------------------------|----------------------------------------------|-------------|
| Human serum or plasma | Human serum or plasma | Same |
Product Type
| Diazyme LDL-Cholesterol Reagent | Genzyme N-Geneous LDL Cholesterol
Reagent | Equivalency |
|---------------------------------|----------------------------------------------|-------------|
| Calibrator, Reagent, Instrument | Calibrator, Reagent, Instrument | Same |
Performance
| Diazyme LDL-Cholesterol Reagent | Genzyme N-Geneous LDL Cholesterol Reagent |
|---|---|
| Reportable Range: | |
| Serum: 2.04 - 250 mg/dL | Reportable Range: |
| Serum: 6.6-992mg/dL | |
| Precision/Serum: | |
| Within Run: 0.7% -1.0% | |
| Total: 1.4%-1.6% | Precision/Serum: |
| Within Run: 0.62% -0.73% | |
| Total: 1.73%-2.27% | |
| Accuracy/Serum: | |
| Correlation Coefficient: 0.9804 | |
| Slope/Intercept: | |
| y = 1.0883x + 0.6078 mg/dL | Accuracy/Serum: |
| Correlation Coefficient: 0.96 | |
| Slope/Intercept: | |
| y = 0.95x + 3.02mg/dL |
Calibrator Comparison
| Diazyme LDL Cholesterol Calibrator | Genzyme N-Geneous LDL Cholesterol
Calibrator | Equivalency |
|---------------------------------------------------------------|-----------------------------------------------------------------------------|-------------|
| Lyophilized form | Lyophilized form | Same |
| LDL Cholesterol calibrator is traceable to NIST
SRM 1915b. | LDL N-Geneous calibrator is traceable to
the CDC HDL reference method**. | Same |
** National Reference System for Cholesterol. CRMLN LDL Cholesterol Protocol, May 2004.
:
·
3
Rationale for Considering the Device Substantially Equivalent to Devices Approved for Interstate Commerce
Genzyme N-geneous LDL Cholesterol Reagent (K971573) was selected for comparing serum samples with to the results generated by Diazyme LDL-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 LDL-Cholesterol Reagent is similar to the approved predicate test. The minor differences in the performances of the tests should not affect the safety and effectiveness of the Diazyme LDL - Cholesterol Reagent and offers users an in-vitro diagnostic device to measure LDL Cholesterol in human serum or plasma.
In summary, the dissimilar features between the Diazyme LDL-Cholesterol Reagent and devices 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 LDL-Cholesterol Reagent with those obtained using the predicate device, Genzyme N-geneous LDL Cholesterol Reagent (K971573).
4
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), whereas HDL reacts with the enzymes. Addition of R2 containing a specific detergent releases LDL from the PVS/PEGME complex. The released LDL reacts with the enzymes to produce H2O2 which is quantified by the Trinder reaction.
PVS HDL + LDL + VLDL + CM = + PEGME HDL + (LDL + VLDL + CM ) · PVS/PEGME HDL + CHER - -- Fatty Acid + H3O2 Detergent (LDL + VLDL + CM)· PVS/PEGME LDL + (VLDL + CM) · PVS/PEGME LDL + CHOD + CHER ------------------------------------------------------------------------------------------------------------------------------------------------------------Peroxidase 2H2O2 +4-AA+TODB -------------------------------------------------------------------------------------------------------------------------------------------------------------(2-max=560nm)
Intended Use of the Device:
The Diazyme LDL-Cholesterol Reagent is intended for the in vitro quantitative determination of Low 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. Elevated LDL cholesterol is the primary target of cholesterol-lowering therapy.
Performance Characteristics
Diazyme LDL-Cholesterol Reagent is a homogeneous two-reagent enzymatic assay. The results are obtained in 10 minutes by measuring absorbance at 600 nm. The linearity of the assay is from 1.64 -830 mg/dL for serum samples. The assay offers excellent precision as shown in the tables below:
| Serum Testing | Level 1
95mg/dL LDL | Level 2
146mg/dL LDL | Level 3
210mg/dL LDL |
|----------------------|------------------------|-------------------------|-------------------------|
| Within-Run Precision | $C_v$ % = 1.0% | $C_v$ % = 0.8% | $C_v$ % = 0.7% |
| Total Precision | $C_v$ % = 1.6% | $C_v$ % = 1.5% | $C_v$ % = 1.4% |
In method comparison studies, samples tested with Diazyme LDL-Cholesterol Reagent showed good correlation with Genzyme N-geneous LDL Cholesterol Reagent (K971573) with correlation coefficients of 0.996 for serum samples.
5
We have conducted interference studies by spiking normal pooled human serum samples with substances normally present in serum or plasma and found less than 10% interference at the indicated concentrations.
| Interference Study | |
|---|---|
| Substance | Concentration |
| Triglycerides | 1000 mg/dL |
| Ascorbic acid | 10 mmol/L |
| Bilirubin | 40 mg/dL |
| Bilirubin Conjugated | 40 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 LDL-Cholesterol Reagent has excellent accuracy and is safe and effective. There is no significant deviation between the results obtained by Diazyme LDL-Cholesterol Reagent and the legally marketed predicate device (K971573) when testing clinical patient samples and is therefore substantially similar.
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its head turned to the left and its wings outstretched. The eagle is composed of three thick, black lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
JAN 22 2008
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
General Atomics Diazyme Laboratories Division c/o Mr. Charles Yu 12889 Gregg Court Poway, CA 92064
Re: K072523
Trade/Device Name: Diazyme LDL-Cholesterol Reagent Regulation Number: 21 CFR§862.1475 Regulation Name: Lipoprotein Test System Regulatory Class: Class I Product Code: LBR, JJX Dated: November 12, 2007 Received: November 15, 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).
7
Page 2 -
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.
Jean 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
8
Indications for Use
| 510(k) Number: | K 072523 |
|---|---|
| Device Name: | Diazyme LDL-Cholesterol Reagent |
| Indications for Use: | The Diazyme LDL-Cholesterol Assay is intended for the in vitro quantitative |
| determination of Low 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. Elevated LDL cholesterol is the | |
| primary target of cholesterol-lowering therapy. | |
| Calibrator: | For calibration of the Diazyme LDL-Cholesterol Reagent Assay in |
| serum or plasma. | |
| For In Vitro Diagnostic Use | |
| Controls: | To monitor the performance of Diazyme LDL-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)
| Signature | Carol Benson Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) |
|---|---|
| Division Sign-Off |
510(k) Summary
| Office of In Vitro Diagnostic Device | |
|---|---|
| Evaluation and Safety | 15 |