(138 days)
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No
The device description and performance studies focus on a standard immunoturbidimetric assay method, with no mention of AI or ML algorithms for data analysis or interpretation.
No
This device is for in vitro quantitative determination of lipoprotein(a) (Lp(a)) concentration, which is used for evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular diseases. It is a diagnostic tool, not a therapeutic device designed to treat or alleviate a disease.
Yes
This device is intended for the quantitative determination of lipoprotein(a) [Lp(a)] concentration, which is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular diseases. This indicates its use in aiding in the diagnosis or assessment of specific medical conditions.
No
The device is an in vitro diagnostic (IVD) assay kit, which includes reagents and controls for a laboratory test. It is not a software-only medical device.
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 Diazyme Lp(a) is intended for the "in vitro quantitative determination of lipoprotein(a) [Lp(a)] concentration in human serum er plasma (EDTA)". This clearly indicates that the device is used to test samples taken from the human body outside of the body.
- Device Description: The description details a laboratory assay based on an immunoturbidimetric method, which is a common technique used in in vitro diagnostics.
- Performance Studies: The performance studies describe testing of human serum and plasma samples, further supporting its use as an in vitro diagnostic.
- Predicate Device: The mention of a predicate device (K013359; Lp(a)-LATEX SEIKEN ASSAY KIT) which is also an Lp(a) assay, strongly suggests that this device falls within the category of in vitro diagnostics.
The term "in vitro" in the intended use is the most direct indicator that this is an IVD.
N/A
Intended Use / Indications for Use
The Diazyme Lp(a) immunoassay is intended for the in vitro quantitative determination of Lipoprotein (a) in human serum and plasma.
The Diazyme Lipoprotein (a) [Lp(a)] Assay and Lipoprotein (a) Assay Calibrator Set are intended for the in vitro quantitative determination of lipoprotein (a) in serum or plasma.
The Diazyme Lp(a) is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of lipoprotein(a) [Lp(a)] concentration in human serum er plasma (EDTA) on Clinical Chemistry Systems. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular diseases in specific populations, when used in conjunction with clinical evaluation.
Diazyme Lp(a) Control is intended for use in monitoring the quality control of results obtained with the Diazyme Lp(a) reagents by turbidimetry.
Diazyme Lp(a) standard is intended for use in establishing the calibration curve for the Diazyme Lp(a) reagents by turbidimetry.
Product codes (comma separated list FDA assigned to the subject device)
DFC, JIS, JJX
DFC, JIT, JJX
Device Description
Lipoprotein (a) is a cholesterol-rich lipoprotein particle found in human serum. There is substantial evidence linking lipoprotein (a) excess to a high risk for premature coronary heart disease (CHD), increased risk of myocardial infraction (MI) and stroke, and restenosis after angioplasty (PTCA) and coronary bypass procedures. Lipoprotein (a) has been called a powerful predictor of premature atherosclerotic vascular disease.
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
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision:
The precision of the Diazyme Lp(a) Enzymatic Assay was evaluated according to Clinical and Laboratory Standards Institute (formerly NCCLS) EP5-A guideline.
Sample size: Three levels of serum specimens (17.2, 43.2, and 70.0 mg/dL Lp(a)).
Results:
Within-Run Precision: Level 1 Cv% = 2.6%, Level 2 Cv% = 1.4%, Level 3 Cv% = 1.1%.
Total Precision: Level 1 Cv% = 3.6%, Level 2 Cv% = 3.3%, Level 3 Cv% = 2.4%.
Accuracy:
Correlation studies were performed by testing 76 serum samples in comparison with an existing commercial Lp(a) assay method.
Results:
Serum: Correlation Coefficient: 0.9983, Slope/Intercept: y = 0.9891x + 0.0947.
Plasma: Correlation Coefficient: 0.9803, Slope/Intercept: y = 0.9895/0.0279.
Conclusion: The result summary indicates good agreement with legally marketed assay.
Interference:
Interference studies were conducted by spiking human serum samples with substances normally present in serum.
Results: Less than 10% interference was found at the indicated concentrations for Triglycerides (1000 mg/dL), Ascorbic acid (10 mmol/L), Bilirubin (40 mg/dL), Bilirubin Conjugated (40 mg/dL), and Hemoglobin (1000 mg/dL).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 866.5600 Low-density lipoprotein immunological test system.
(a)
Identification. A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.(b)
Classification. Class II (performance standards).
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Pre-market Notification Diazyme Lp(a) Assay
Koryyr
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: | Dr. Abhijit Datta | |
| Diazyme Laboratories | ||
| 12889 Gregg Court | ||
| Poway, CA 92064 | ||
| Phone: 858-455-4762 | ||
| Fax: 858-455-2120 | JAN 13 2009 | |
| Date the Summary was Prepared: | Aug 26, 2008; Dec 1, 2008 | |
| Name of the Device | Diazyme Lipoprotein (a) Assay | |
| Trade Name: | Diazyme Lp(a) Assay | |
| Common/Usual Name | Lp(a) Test System | |
| Device Classification Name | Low Density Lipoprotein Immunological Test System | |
| Product code: | DFC, JIS, JJX | |
| Submission Type | 510k | |
| Regulation Number | 866.5600, 862.1150, 862.1660 | |
| Device Class | II | |
| Predicate Device: | For the Lipoprotein (a) Immunological Test System Lipo- | |
| protein test system, we are claiming equivalence to Lp(a)- | ||
| LATEX SEIKEN ASSAY KIT manufactured by Denka | ||
| Seiken Co. Ltd |
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Substantial Equivalence Information
-
l. Predicate device name(s):
Lp(a) Assay -
- Predicate 510(k) number(s):
K013359
- Predicate 510(k) number(s):
3. . Comparison with predicate:
Indications for Use
| Diazyme Lp(a) Assay | Denka Lp(a) Assay | Equivalency |
|---|---|---|
| The Diazyme Lp(a) immunoassay is | ||
| intended for the in vitro quantitative | ||
| determination of Lipoprotein (a) in human | ||
| serum and plasma. | The Lp(a) Assay is a latex in vitro diag- | |
| nostic immunoassay for the quantitative | ||
| determination of Lipoprotein (a) in | ||
| human serum and plasma. | Same |
Principle
| Diazyme Lp(a) Assay | Denka Lp(a) Assay | Equivalency |
|---|---|---|
| The Diazyme Lipoprotein (a) Assay is | ||
| based on a latex enhanced immunoturbidi- | ||
| metric assay. Lp(a) in the sample binds to | ||
| specific anti-Lp(a) antibody, which is | ||
| coated on latex particles, and causes agglu- | ||
| tination. The degree of the turbidity caused | ||
| by agglutination can be measured optically | ||
| and is proportional to the amount of Lp(a) | ||
| in the sample. | The Lp(a)-Latex Seiken Assay kit is a latex- | |
| enhanced immunoturbidimetric in vitro diag- | ||
| nostic assay. Lp(a) in the sample binds to the | ||
| specific anti-Lp(a) antibody, which is ad- | ||
| sorbed to latex particles and agglutinates. The | ||
| agglutination is detected as an absorbance | ||
| change when read on an automated chemistry | ||
| analyzer (at 700 nm). The magnitude of the | ||
| change is proportional to the quantity of | ||
| Lp(a) in the sample. The actual concentration | ||
| is then determined by interpolation from a | ||
| calibration curve prepared from calibrators of | ||
| know concentrations. | Same |
Test Objective
| Diazyme Lp(a) Assay | Denka Lp(a) Assay | Equivalency |
|---|---|---|
| For the in vitro quantitative determination | ||
| of lipoprotein (a) in serum or plasma. | For the in vitro quantitative determination | |
| of lipoprotein (a) in serum or plasma us- | ||
| ing automated chemistry analyzers. | Same |
Type of Test
:
| Diazyme Lp(a) Assay | Denka Lp(a) Assay | Equivalency |
|---|---|---|
| Quantitative | Quantitative | Same |
Specimen Type
| Diazyme Lp(a) Assay | Denka Lp(a) Assay | Equivalency |
|---|---|---|
| Human serum and plasma | Human serum and plasma | Same |
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.
Product Type
| Diazyme Lp(a) Assay | Denka Lp(a) Assay | Equivalency |
|---|---|---|
| Calibrator, Reagent, Instrument | Calibrator, Reagent, Instrument | Same |
Performance
| Diazyme Lp(a) Assay | Denka Lp(a) Assay |
|---|---|
| Reportable Range: | |
| Serum: 5.44 mg/dL to 100.0 mg/dL | |
| Plasma: 5.44 mg/dL to 100.0 mg/dL | Reportable Range: |
| Serum: 0.5mg/dL to 80.0 mg/dL | |
| Plasma: 0.5mg/dL to 80.0 mg/dL | |
| Precision/Serum: | |
| Within Run: 1.1% - 2.6% | |
| Total: 2.4% - 3.6% | Precision/Serum: |
| Within Run: 1.26% - 2.00% | |
| Total: 0.99% - 2.22% | |
| Accuracy/Serum: | |
| Correlation Coefficient: 0.998 | |
| Slope/Intercept: | |
| $y = 0.9895x + 0.0279$ | Accuracy/Serum: |
| Correlation Coefficient: 0.989 | |
| Slope/Intercept: | |
| $y = 1.108x - 1.44$ | |
| Accuracy/Plasma: | |
| Correlation Coefficient: 0.9803 | |
| Slope/Intercept: | |
| $y = 1.044x + 0.0407$ | Accuracy/Plasma: |
| Correlation Coefficient: 0.990 | |
| Slope/Intercept: | |
| $y = 1.079x - 0.16$ |
Calibrator Comparison
| Diazyme Lp(a) Assay | Denka Lp(a) Assay | Equivalency |
|---|---|---|
| Lyophilized form | Lyophilized form | Same |
Control Comparison
| Diazyme Lp(a) Assay | Denka Lp(a) Assay | Equivalency |
|---|---|---|
| Lyophilized form | Lyophilized form | Same |
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Rationale for Considering the Device Substantially Equivalent to Devices Approved for Interstate Commerce
The Denka Lp(a) Assay (K013359) was selected for method comparison testing of human serum and plasma samples with the Diazyme Lp(a) Assay. 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 Lp(a) Assay is substantially 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 Lp(a) Assay and offers users an in-vitro diagnostic device to measure Lp(a) in human serum and plasma.
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Description of the Device
Lipoprotein (a) is a cholesterol-rich lipoprotein particle found in human serum. There is substantial evidence linking lipoprotein (a) excess to a high risk for premature coronary heart disease (CHD), increased risk of myocardial infraction (MI) and stroke, and restenosis after angioplasty (PTCA) and coronary bypass procedures. Lipoprotein (a) has been called a powerful predictor of premature atherosclerotic vascular disease. Therefore measurement of lipoprotein(a) is now recommended in several patient subgroups for whom excess lipoprotein(a) may have important clinical consequences: (1) patients with premature athero-sclerosis, (2) patients with a strong family history of premature coronary heart disease (CHD), (3) patients with elevated LDL-C and greater than or equal to two risk factors, (4) patients who have had coronary angioplasty in whom lipoprotein(a) excess may increase the risk of restenosis, and (5) patients who have undergone coronary bypass graft surgery in whom Lp(a) excess may be associated with graft stenosis.
Intended Use of the Device:
The Diazyme Lipoprotein (a) [Lp(a)] Assay and Lipoprotein (a) Assay Calibrator Set are intended for the in vitro quantitative determination of lipoprotein (a) in serum or plasma.
Performance Testing Summaries
Precision
The Diazyme Lipoprotein (a) Assay is based on a latex enhanced immunoturbidimetric assay. Lp(a) in the sample binds to specific anti-Lp(a) antibody, which is coated on latex particles, and causes agglutination. The degree of the turbidity caused by agglutination can be measured optically and is proportional to the amount of Lp(a) in the sample.
The precision of the Diazyme Lp(a) Enzymatic Assay was evaluated according to Clinical and Laboratory Standards Institute (formerly NCCLS) EP5-A guideline. In the study, three levels of serum specimens containing about 17.2, 43.2, and 70.0 mg/dL Lp(a) respectively are tested with 2 runs per day with duplicates over 20 working days.
| Serum Testing | Level 1 | Level 2 | Level 3 |
|---|---|---|---|
| Within-Run Precision | $C_v% = 2.6%$ | $C_v% = 1.4%$ | $C_v% = 1.1%$ |
| Total Precision | $C_v% = 3.6%$ | $C_v% = 3.3%$ | $C_v% = 2.4%$ |
Accuracy
Correlation studies were performed by testing 76 serum samples in comparison with an existing commercial Lp(a) assay method. The result summary indicates good agreement with legally marketed assay.
Accuracy Summary:
Serum: Correlation Coefficient: 0.9983 Slope/Intercept:
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y = 0.9891x + 0.0947
Plasma: Correlation Coefficient: 0.9803 Slope/Intercept: y = 0.9895/0.0279
Interference
We have conducted interference studies by spiking human serum samples with substances normally present in serum 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: Detailed comparison analysis presented in this 510k submission, together with linearity, precision and interference and other detailed studies, demonstrates that the Diazyme Lp(a) Assay has excellent accuracy and is safe and effective. There is no significant deviation between the results obtained by Diazyme Lp(a) Assay and the legally marketed predicate device (K013359) when testing clinical patient samples and is therefore substantially similar.
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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is an abstract emblem resembling an eagle or bird-like figure with stylized feathers.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
General Atomics Diazyme Laboratories c/o Dr. Abhiiit Datta 12889 Gregg Court Poway, CA 92064
JAN 1 3 2009
Re: K082488
Trade/Device Name: Diazyme LP(a) assay Regulation Number: 21 CFR 866.5600 Regulation Name: Low-Density Lipoprotein Immunological Test System. Regulatory Class: Class II Product Code: DFC, JIT, JJX Dated: December 1, 2008 Received: December 4, 2008
Dear Dr. Datta:
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 of your device to a results 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 (301) 594-3084. Also, please not the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 tolla die (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours.
Cott C. Hh
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
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Indication for Use
510(k) Number (if known): K082488
Device Name: Diazyme Lp(a) Assay
Indication For Use:
The Diazyme Lp(a) is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of lipoprotein(a) [Lp(a)] concentration in human serum er plasma (EDTA) on Clinical Chemistry Systems. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular diseases in specific populations, when used in conjunction with clinical evaluation.
Diazyme Lp(a) Control is intended for use in monitoring the quality control of results obtained with the Diazyme Lp(a) reagents by turbidimetry.
Diazyme Lp(a) standard is intended for use in establishing the calibration curve for the Diazyme Lp(a) reagents by turbidimetry.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol Benson
ﯽ
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 1682488
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