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The Diazyme Apolipoprotein B Assay is intended for the quantitative determination of apolipoprotein B (apo B) in serum. It can be used as an aid for assessing the risk of coronary artery disease. For in vitro Diagnostic use.
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The Diazyme Apolipoprotein B Assay is a device intended for the quantitative determination of apolipoprotein B (apo B) in serum, to be used as an aid for assessing the risk of coronary artery disease.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state "acceptance criteria" in a quantitative sense with specific thresholds. However, it presents "Performance" data for the Diazyme Apolipoprotein B Assay and compares it to a predicate device (K-Assay Apo B Assay) to demonstrate substantial equivalence. The implication is that the performance of the Diazyme assay should be comparable or better than the predicate for regulatory acceptance.
Implicit Acceptance Criteria (inferred from predicate comparison): The Diazyme Apolipoprotein B Assay should demonstrate comparable or improved performance relative to the legally marketed K-Assay Apo B Assay, particularly in terms of reportable range, precision (within-run and total), and accuracy (correlation coefficient and slope/intercept).
| Performance Metric | Predicate Device (K-Assay Apo B Assay) | Developed Device (Diazyme Apolipoprotein B Assay) | Implied Acceptance Criteria (relative to predicate) | Device Performance | Meets Criteria (Based on comparative data) |
|---|---|---|---|---|---|
| Reportable Range (Serum) | 25 – 250 mg/dL | 25.0 – 160 mg/dL | Comparable range is desirable. | 25.0 – 160 mg/dL | Acceptable (slightly narrower upward bound) |
| Precision (Within-Run) | 1.44% - 2.12% | 1.2% - 1.4% | Equal to or better (lower %CV) | 1.2% - 1.4% | Meets (Improved) |
| Precision (Total) | 1.09% - 2.33% | 2.1% – 4.8% | Equal to or better (lower %CV) | 2.1% - 4.8% | Acceptable (within a comparable magnitude) |
| Accuracy (Correlation Coefficient) | 0.885 | 0.9864 | Equal to or better (closer to 1) | 0.9864 | Meets (Improved) |
| Accuracy (Slope/Intercept) | $y = 1.442x + 0.00$ mg/dL | $y = 1.0143x - 4.3806$ mg/dL | Slope closer to 1, intercept closer to 0 | $y = 1.0143x - 4.3806$ mg/dL | Meets (Improved) (Slope is closer to 1 and intercept is closer to 0) |
The study demonstrates that the Diazyme Apolipoprotein B Assay's performance is comparable to, and in several key areas (precision within-run, correlation coefficient, and slope/intercept for accuracy), better than the predicate device. This supports the claim of substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). The performance data is presented as summary statistics (ranges for precision, correlation coefficient, slope/intercept).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For in vitro diagnostic devices like the Diazyme Apolipoprotein B Assay, "ground truth" typically refers to reference methods and established standards. The document mentions that the calibrator value is "traceable to the WHO/IFCC Reference Standard" and "WHO International Reference Material for Apo B, SP3-07," which are the established reference points for accuracy. There's no mention of human experts establishing ground truth for individual samples.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1, none) are typically relevant for studies involving human interpretation of images or clinical assessments where discrepancies between readers might occur. For an automated in vitro diagnostic assay, this concept does not directly apply. The "ground truth" is based on reference methods and established standards for the analyte measurement, not expert consensus on individual case interpretation.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
An MRMC study is not applicable nor indicated for this type of in vitro diagnostic device. MRMC studies evaluate the performance of human readers, sometimes with and without AI assistance, especially in radiology or pathology. This device is an automated biochemical assay.
6. Standalone Performance Study
Yes, a standalone performance assessment was done. The "Performance" section explicitly lists metrics for the Diazyme Apolipoprotein B Assay such as:
- Reportable Range: 25.0 – 160 mg/dL
- Precision (Within Run): 1.2% -1.4%
- Precision (Total): 2.1%–4.8%
- Accuracy (Correlation Coefficient): 0.9864
- Accuracy (Slope/Intercept): $y = 1.0143x - 4.3806$ mg/dL
These figures represent the performance of the algorithm/assay itself, without human intervention in the measurement process. The comparison to the predicate device further contextualizes this standalone performance for regulatory purposes.
7. Type of Ground Truth Used
The ground truth for the device's performance is based on:
- Reference Standards: The calibrator values are traceable to "WHO/IFCC Reference Standard" and "WHO International Reference Material for Apo B, SP3-07." These are internationally recognized reference materials that establish the true concentration of Apolipoprotein B.
- Comparative Measurements: Accuracy is shown through correlation and regression against a legally marketed predicate device (K-Assay Apo B Assay), implying that the predicate's measurements serve as a comparative standard.
8. Sample Size for the Training Set
This information is not provided in the document. For an immunoturbidimetric assay, "training set" doesn't have the same meaning as in machine learning algorithms. The development process would involve calibration and optimization using characterized materials, but not a "training set" in the common AI sense.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" with established ground truth is generally not applicable in the same way for an immunoturbidimetric assay as it would be for AI/ML devices. The "ground truth" for the development and calibration of such an assay would be established using certified reference materials and calibrators with known, traceable concentrations of Apolipoprotein B, as mentioned for the calibrator's traceability to WHO/IFCC standards.
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Ko73488
MAR - 7 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 CourtPoway, CA 92064USA |
| Name of Contact Person: | Charles YuDiazyme Laboratories12889 Gregg CourtPoway, CA 92064Phone: 858-455-4761Fax: 858-455-4750 |
| Date the Summary was Prepared: | September 24, 2007 |
| Name of the Device | Diazyme Apolipoprotein B Assay |
| Trade Name: | Diazyme Apolipoprotein B Assay |
| Common/Usual Name | Apolipoprotein B Test System |
| Device Classification Name | Alpha-1-lipoprotein Immunological Test System |
| Reagents | |
| Product code: | MSJ |
| Submission Type | 510k |
| Regulation Number | 862.1475 |
| Device Class | II |
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Calibrator
| Product code: | JIT |
|---|---|
| Submission Type | 510k |
| Regulation Number | 862.1150 |
| Device Class | II |
| Control | |
| Product code: | JJX |
| Submission Type | 510k |
| Regulation Number | 862.1660 |
| Device Class | I Reserved |
| Predicate Device: | For the Alpha-1-lipoprotein Immunological Test SystemLipoprotein test system, we are claiming equivalence[807.92(a) (3) to K-ASSAY APO B ASSAY (K993354)manufactured by Kamiya Biomedical Company |
.
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Substantial Equivalence Information
1. Predicate device name(s):
K-Assay Apo B Assay
-
- Predicate 510(k) number(s): K993354
3. Comparison with predicate:
Indications for Use
| Diazyme Apolipoprotein B Assay | K-Assay Apo B Assay | Equivalency |
|---|---|---|
| The Diazyme Apolipoprotein B Assay is intended for the quantitative determination of apolipoprotein B (apo B) in serum. It can be used as an aid for assessing the risk of coronary artery disease. | For the quantitative determination of human Apolipoprotein B (Apo B) in serum by immunoturbidimetric assay. | Same |
Principle
| Diazyme Apolipoprotein B Assay | K-Assay Assay | Equivalency |
|---|---|---|
| This method is based on the reaction of asample containing human Apo B and a spe-cific antiserum to form an insoluble complexwhich can be measured turbidimetrically at340nm. By constructing a standard curvefrom the absorbance of standards the concen-tration of Apo B can be determined. | This method quantifies Apolipoprotein AIbased on immunoturbidimetric assay. Thereagent uses a goat polyclonal antibodyspecific for human Apolipoprotein B. Theantibody binds to the Apo B in the serumforming light scattering immune com-plexes, which increase the turbidity of thesample. Since the turbidity is proportionalto the amount of Apo B in the sample, theApolipoprotein B concentration can be de-termined by measuring this increase in tur-bidity. The increase in turbidity is meas-ured at 600 nm. Apolipoprotein B in thesample is quantitatively determined. | Similar |
Test Objective
| Diazyme Apolipoprotein B Assay | K-Assay Apo B Assay | Equivalency |
|---|---|---|
| The Diazyme Apolipoprotein B Assay isintended for the quantitativedetermination of apolipoprotein B (apoB) in serum. It can be used as an aid forassessing the risk of coronary arterydisease. | For the quantitative determination of hu-man Apolipoprotein B (Apo B) in serum byimmunoturbidimetric assay. | Same |
| Diazyme Apolipoprotein B Assay | ||
|---|---|---|
| a verse some and a video a video a management - from the management of the responsible of the same of the same of | Apo B Assay | 1 |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | IK-Assav | Equivalency |
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| Quantitative | Quantitative | Same |
|---|---|---|
| -------------- | -------------- | ------ |
Specimen Type
| Diazyme Apolipoprotein B Assay | K-Assay Apo B Assay | Equivalency |
|---|---|---|
| Human serum | Human serum | Same |
Product Type
'
| Diazyme Apolipoprotein B Assay | K-Assay Apo B Assay | Equivalency |
|---|---|---|
| Calibrator, Reagent, Instrument | Calibrator, Reagent, Instrument | Same |
Performance
| Diazyme Apolipoprotein B Assay | K-Assay Apo B Assay |
|---|---|
| Reportable Range: | Reportable Range: |
| Serum: 25.0 – 160 mg/dL | Serum: 25 – 250 mg/dL |
| Precision/Serum: | Precision/Serum: |
| Within Run: 1.2% -1.4% | Within Run: 1.44% -2.12% |
| Total: 2.1%–4.8% | Total: 1.09%–2.33% |
| Accuracy/Serum: | Accuracy/Serum: |
| Correlation Coefficient: 0.9864 | Correlation Coefficient: 0.885 |
| Slope/Intercept: | Slope/Intercept: |
| $y = 1.0143x - 4.3806$ mg/dL | $y = 1.442x + 0.00$ mg/dL |
Calibrator Comparison
| Diazyme Apolipoprotein B Assay | K-Assay Apo B Assay | Equivalency |
|---|---|---|
| Lyophilized form | Lyophilized form | Same |
| Diazyme Apolipoprotein B calibrator value istraceable to the WHO/IFCC Reference Stan-dard. | K-Assay Apo B calibrator value is traceableto the WHO International ReferenceMaterial for Apo B, SP3-07. | Same |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three stripes representing the three levels of government. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
General Atomics Diazyme Laboratories Division, c/o Mr. Charles Yu
MAR - 7 2008
Quality System Manager 12889 Gregg Court Poway, CA 92064
Re: K073488
Trade Name: Diazyme Apolipoprotein B Assay Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class II Product Codes: MSJ, JIT, JJX Dated: February 21, 2008 Received: February 22, 2008
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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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 vou 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
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Indications for Use
| 510(k) Number: | K073488 |
|---|---|
| Device Name: | Diazyme Apolipoprotein B Assay |
| Indications for Use: | The Diazyme Apolipoprotein B Assay is intended for the quantitativedetermination of apolipoprotein B (apo B) in serum. It can be used as an aidfor assessing the risk of coronary artery disease. For in vitro Diagnostic use. |
| Calibrator: | For calibration of the Diazyme Apolipoprotein B Assay in serum. For in vitroDiagnostic Use. |
| Controls: | To monitor the performance of Diazyme Apolipoprotein B Assay in serum. Forin 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)
A
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K073488
§ 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.