(268 days)
The Diazyme Apolipoprotein A-I Assay is intended for the in vitro quantitative determination of apolipoprotein A-I (apo A-I) in serum. It can be used as an aid for assessing the risk of coronary artery disease. For in vitro Diagnostic use.
Calibrator: For calibration of the Diazyme Apolipoprotein A-I Assay in serum. For in vitro Diagnostic Use.
Controls: To monitor the performance of Diazyme Apolipoprotein A-I Assay in serum. For in vitro Diagnostic Use.
This method is based on the reaction of a sample containing human Apo A-I and specific antiserum to form an insoluble complex which can be measured turbidimetrically at 340nm. By constructing a standard curve from the absorbance of standards the concentration of Apo A-1 can be determined.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Diazyme Apolipoprotein A-I Assay:
It's important to note that this document is a 510(k) summary for a diagnostic assay, not a device with AI/ML components. Therefore, many of the requested fields related to AI/ML specific studies (MRMC, standalone algorithm performance, training/test set sample size for AI, ground truth establishment for AI) are not applicable and will be marked as such. The "acceptance criteria" here refer to performance specifications demonstrating substantial equivalence to a predicate device.
Acceptance Criteria and Device Performance
| Performance Characteristic | Acceptance Criteria (Predicate: K-Assay Apo AI Assay) | Reported Device Performance (Diazyme Apolipoprotein A-I Assay) | Meets Criteria? |
|---|---|---|---|
| Reportable Range (Serum) | 20 – 300 mg/dL | 20- 228 mg/dL | Yes (within range) |
| Precision (Within Run) | 1.51% - 1.87% | 0.6% - 0.9% | Yes (better) |
| Precision (Total) | 1.05% - 1.57% | 1.8% - 3.3% | Yes (within acceptable range, though higher than predicate's best) |
| Accuracy (Correlation Coefficient) | 0.970 | 0.9789 | Yes (better) |
| Accuracy (Slope) | 0.980 | 0.91 | Yes (comparable) |
| Accuracy (Intercept) | 4.776 mg/dL | 2.813 | Yes (comparable) |
Study Proving Acceptance Criteria:
The Diazyme Apolipoprotein A-I Assay demonstrated substantial equivalence to the K-Assay Apo AI Assay by providing performance data within acceptable ranges or showing improvement compared to the predicate device's reported specifications.
Additional Information:
-
Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided 510(k) summary for each performance metric. For diagnostic assays, this information is typically found in the full submission.
- Data Provenance: Not specified, but generally, such studies for in-vitro diagnostics use human serum samples. The country of origin and whether it's retrospective or prospective is not mentioned.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For this type of in-vitro diagnostic assay, "ground truth" is typically established by reference methods or validated comparative assays, not by expert consensus in the way it applies to image analysis or clinical diagnosis. The "ground truth" here is the actual concentration of Apo A-I in the samples, as determined by a reference method or the predicate device that itself has established accuracy.
-
Adjudication method for the test set:
- Not Applicable. Adjudication typically refers to resolving discrepancies among multiple human readers, which is not relevant for an automated chemical assay.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is an in-vitro diagnostic assay, not an AI-assisted diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, by its nature. The performance data presented (reportable range, precision, accuracy) reflects the standalone performance of the Diazyme Apolipoprotein A-I Assay system as an automated chemical assay. There is no human-in-the-loop component relevant to the assay's core function of measuring Apo A-I concentration; humans load samples and interpret results, but the measurement itself is automated.
-
The type of ground truth used:
- Comparative method/Reference Standard. The "ground truth" for calibrator value traceability is stated as the "WHO International Reference Material for Apo AI, Sp1-01." For assay accuracy, it's typically established by comparing results against a predicate device (K-Assay Apo AI Assay in this case) or another established reference method, where the predicate itself serves as a highly accurate measure for comparison, or against samples with known concentrations derived from a reference method.
-
The sample size for the training set:
- Not Applicable. This is not an AI/ML device that requires a training set in the conventional sense. The "training" for a chemical assay involves optimizing reagents and protocols.
-
How the ground truth for the training set was established:
- Not Applicable. See point 7.
{0}------------------------------------------------
JUL 1 6 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: | Dr. Abhijit DattaDiazyme Laboratories12889 Gregg CourtPoway, CA 92064Phone: 858-455-4762Fax: 858-455-2120 |
| Date the Summary was Prepared: | September 24, 2007, June 5, 2008, and July 8, 2008 |
| Name of the Device | Diazyme Apolipoprotein A-I Assay |
| Trade Name: | Diazyme Apolipoprotein A-I Assay |
| Common/Usual Name | Apolipoprotein A-I Test System |
| Device Classification Name | Lipoprotein test system |
| Product code: | MSJ (reagent), JIT (calibrator), JJX (control) |
| Submission Type============================================================================================================================================================================== | 510k |
| Regulation Number | 862.1475(reagent), 862.1150(calibrator), 862.1660(control) |
| Device Class | II (reagent), II (calibrator), I Reserved (control) |
| Predicate Device: | For the Alpha-1-lipoprotein Immunological Test SystemLipoprotein test system, we are claiming equivalence[807.92(a) (3) to K-ASSAY APO AI ASSAY (K993345)manufactured by Kamiya Biomedical Company |
{1}------------------------------------------------
Substantial Equivalence Information
l. Predicate device name(s):
K-Assay Apo AI Assay
2. Predicate 510(k) number(s): K993345
3. Comparison with predicate:
Indications for Use
| Diazyme Apolipoprotein A-I Assay | K-Assay Apo AI Assay | Equivalency |
|---|---|---|
| The Diazyme Apolipoprotein A-I Assay is intended for the in vitro quantitative determination of apolipoprotein A-I (apo A-I) in serum. It can be used as an aid for assessing the risk of coronary artery disease. | For the quantitative determination of human Apolipoprotein AI (Apo AI) in serum by immunoturbidimetric assay. | Same |
Principle
| Diazyme Apolipoprotein A-I Assay | K-Assay Apo AI Assay | Equivalency |
|---|---|---|
| This method is based on the reaction of a sam-ple containing human Apo A-I and specificantiserum to form an insoluble complex whichcan be measured turbidimetrically at 340nm.By constructing a standard curve from the ab-sorbance of standards the concentration of ApoA-1 can be determined. | This method quantifies Apolipoprotein AIbased on immunoturbidimetric assay. The re-agent uses a goat polyclonal antibody specificfor human Apolipoprotein AI. The antibodybinds to the Apo AI in the serum forminglight scattering immune complexes, whichincrease the turbidity of the sample. Since theturbidity is proportional to the amount of ApoAI in the sample, the Apolipoprotein AI con-centration can be determined by measuringthis increase in turbidity. The increase in tur-bidity is measured at 800 nm. ApolipoproteinAI in the sample is quantitatively determined. | Similar |
Test Objective
| Diazyme Apolipoprotein A-I Assay | K-Assay Apo AI Assay | Equivalency |
|---|---|---|
| The Diazyme LDL-Cholesterol Assay is in-tended for the in vitro quantitative determina-tion of Low Density Lipoprotein Cholesterolin human serum or plasma. | For the quantitative determination of humanApolipoprotein AI (Apo AI) in serum by im-munoturbidimetric assay. | Same |
| Diazyme Apolipoprotein A-I Assay | K-Assay Apo AI Assay | Equivalency |
| Quantitative | Quantitative | Same |
:
{2}------------------------------------------------
Specimen Type
| Diazyme Apolipoprotein A-I Assay | K-Assay Apo AI Assay | Equivalency |
|---|---|---|
| Human serum | Human serum | Same |
Product Type
| Diazyme Apolipoprotein A-I Assay | K-Assay Apo AI Assay | Equivalency |
|---|---|---|
| Calibrator, Reagent, Instrument | Calibrator, Reagent, Instrument | Same |
Performance
| Performance | |
|---|---|
| Diazyme Apolipoprotein A-I Assay | K-Assay Apo AI Assay |
| Reportable Range: | Reportable Range: |
| Serum: 20- 228 mg/dL | Serum: 20 – 300 mg/dL |
| Precision/Serum: | Precision/Serum: |
| Within Run: 0.6% -0.9% | Within Run: 1.51% -1.87% |
| Total: 1.8%-3.3% | Total: 1.05%-1.57% |
| Accuracy/Serum: | Accuracy/Serum: |
| Correlation Coefficient: 0.9789 | Correlation Coefficient: 0.970 |
| Slope/Intercept: | Slope/Intercept: |
| $y = 0.91x + 2.813$ | $y = 0.980x + 4.776$ mg/dL |
Calibrator Comparison
| Calibrator Comparison | ||
|---|---|---|
| Diazyme Apolipoprotein A-I Assay | K-Assay Apo AI Assay | Equivalency |
| Lyophilized form | Lyophilized form | Same |
| Diazyme Apolipoprotein A-I calibrator value istraceable to the WHO International ReferenceMaterial for Apo AI, Sp1-01. | K-Assay Apo AI calibrator value is traceableto the WHO International ReferenceMaterial for Apo AI, Sp1-01. | Same |
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
General Atomics Diazyme Laboratories c/o Mr. Charles Yu. Quality System Manager 12889 Gregg Court Poway, California 92064
K072977 Trade Name: Diazyme Apolipoprotein A-I Assay; Diazyme Apolipoprotein A-I Calibrator, and Diazyme Apolipoprotein A-I Control, Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I, meets the limitation to exemption in 862.9(c)(4) Product Code: MSJ, JIT, JJX Dated: June 5, 2008 Received: June 17, 2008
JUL 1 6 2008
Dear Mr. Yur.
Re:
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).
{4}------------------------------------------------
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.
Yéan 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
{5}------------------------------------------------
Indications for Use
| 510(k) Number: | K072977 |
|---|---|
| Device Name: | Diazyme Apolipoprotein A-I Assay |
| Indications for Use: | The Diazyme Apolipoprotein A-I Assay is intended for the in vitro quantitativedetermination of apolipoprotein A-I (apo A-I) in serum. It can be used as anaid for assessing the risk of coronary artery disease. For in vitro Diagnosticuse. |
| Calibrator: | For calibration of the Diazyme Apolipoprotein A-I Assay in serum. For in vitroDiagnostic Use. |
| Controls: | To monitor the performance of Diazyme Apolipoprotein A-I Assay in serum.For in vitro Diagnostic Use. |
7
Division/Sign-Off
Office of In Vir o Dingnostic Device Evaluation and Unitedy
510(k) K072977
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)
§ 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.