(28 days)
No
The device description and performance studies focus on a standard immunoturbidimetric assay for measuring Lp(a), which is a chemical/biological reaction measured optically. There is no mention of AI/ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
This device is for in vitro diagnostic use, intended for establishing calibration curves and monitoring quality control for a Lipoprotein (a) assay, which measures a substance in a sample but doesn't directly treat or intervene in a patient's health.
Yes
The "Intended Use / Indications for Use" states "For in vitro diagnostic use only," and the "Device Description" mentions that the measurement of Lp(a) is "useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular diseases." These indicate that the device provides information for diagnosis.
No
The device is an in vitro diagnostic assay kit, which includes physical reagents (calibrators and controls) used in a laboratory setting, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use only."
- Nature of the Device: The device is a calibrator and control set for an assay that measures a substance (Lipoprotein (a)) in biological samples (serum or plasma). This is the core function of an in vitro diagnostic device – to perform tests on samples taken from the body to aid in diagnosis or monitoring.
- Purpose: The calibrators and controls are used to ensure the accuracy and reliability of the Diazyme Lipoprotein (a) Assay, which is itself an IVD used for evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular diseases.
The information provided strongly indicates that this device is intended for use in a laboratory setting to perform diagnostic tests on patient samples, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Diazyme Lipoprotein (a) Calibrator Set is intended for use in establishing the calibration curve for the Diazyme Lipoprotein (a) Assay reagents by turbidimetry. For in vitro diagnostic use only.
The Diazyme Lipoprotein (a) Control Set is intended for use in monitoring the quality control of results obtained with the Diazyme Lipoprotein (a) Assay reagents by turbidimetry. For in vitro diagnostic use only.
Product codes (comma separated list FDA assigned to the subject device)
JIT, JJX
Device Description
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.
Diazyme Lp(a) standard is intended for use in establishing the calibration curve for the Diazyme Lp(a) reagents by turbidimetry. 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.
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)
The nonclinical performance of the Diazyme Lp(a) Calibrator Set and Control Set was demonstrated through the following studies:
- 20-Day Precision
- Limits of Blank/Detection/Quantitation (LOB/LOD/LOQ)
- Linearity
- Accuracy by Method Comparison
- Accuracy by Matrix Comparison
- Interference
- Accelerated Calibrator Stability
- Real Time Calibrator Stability
- Accelerated Control Stability
- Real Time Control Stability
- Open and Closed Vial Calibrator Stability
- Value Assignment and Traceability
Key results: Current Diazyme Lp(a) Assay reagent and calibrators (K082488) were selected for comparing serum Lp(a) levels to the results generated by the modified device Diazyme Lp(a) Calibrator Set and current Diazyme Lp(a) Assay reagent. The accuracy between the results obtained by Diazyme Lp(a) Assay Kit (K082488) and proposed calibrators and controls (Diazyme Lp(a) Calibrator Set and Control Set) unequivocally demonstrates excellent correlation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Analytical Sensitivity: 5.44 mg/dL
LOB = 1.13 mg/dL
LOQ = 5.44 mg/dL
Dynamic Range: Up to 100 mg/dL Lp(a)
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
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
510(k) Summary (Summary of Safety and Effectiveness)
This summary of the 510(k) safety and effectiveness information is being submitted in the accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number
Applicant Name:
Dr. Abhijit Datta, Director of Technical Operations
Diazyme Laboratories
12889 Gregg Court
Poway, CA 92064
Abhijit.datta(@diazyme.com
Date Summary was Prepared
June 10, 2013
Device Name:
Classification Name: Diazyme Lipoprotein (a) Calibrator Set and Diazyme Lipoprotein (a) Control Set
Trade Name: Diazyme Lp(a) Calibrator Set and Diazyme Lp(a) Control Set
Common Name: Diazyme Lp(a) Calibrator Set and Diazyme Lp(a) Control Set
Governing Regulation: 21 CFR 862.1150 (Calibrator, Primary); 21 CFR 862.1660 [Single (specificed) Analyte Controls (Assayed and Unassayed)]
Device Classification: Low Density Lipoprotein Immunological test system: Class II (Calibrator and Control
Classification Panel: Clinical Chemistry (75)
Product Code: JIT, JJX
Submission Type
Special 510k
Legally marketed device to which equivalency is claimed:
1
K082488. Diazyme Lp(a) calibrators and controls
Manufacturing Address
Diazyme Laboratories
12889 Gregg Court
Poway, CA 92064
Establishment Registration
2032900
Intended Use of Device:
The Diazyme Lipoprotein (a) Calibrator Set is intended for use in establishing the calibration curve for the Diazyme Lipoprotein (a) Assay reagents by turbidimetry. For in vitro diagnostic use only.
The Diazyme Lipoprotein (a) Control Set is intended for use in monitoring the quality control of results obtained with the Diazyme Lipoprotein (a) Assay reagents by turbidimetry. For in vitro diagnostic use only.
Description of Device:
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.
Diazyme Lp(a) standard is intended for use in establishing the calibration curve for the Diazyme Lp(a) reagents by turbidimetry. 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.
Modification of Device:
The significant changes to the device are as follows:
- . Change in state of material supplied from freeze-dried powder to liquid
- . Change in packaging and labeling, specifically the change in catalog number
- . No change to intended use claims
Based on the findings from verification and validation activities, the changes of the Diazyme Lp(a) Calibrator Set and Control Set (compared to predicate) do not alter the safety or effectiveness.
2
Similarities and Difference of Modified Device:
| Attribute | Predicate Device | New Device |
|---|---|---|
| Diazyme Lipoprotein (a) | Diazyme Lipoprotein (a) | |
| Assay with Lyophilized | Calibrator Set and Control | |
| Calibrators and Controls | ||
| (K082488) | Set (special 510k submission) | |
| Intended Use | Diazyme Lp(a) standard is | |
| intended for use in | ||
| establishing the calibration | ||
| curve for the Diazyme Lp(a) | ||
| reagents by turbidimetry. For | ||
| in vitro diagnostic use only | Diazyme Lipoprotein (a) | |
| Calibrator Set is intended for | ||
| use in establishing the | ||
| calibration curve | ||
| for the Diazyme Lipoprotein | ||
| (a) Assay reagents by | ||
| turbidimetry. For in vitro | ||
| diagnostic use only. | ||
| 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 Lipoprotein (a) | |
| Control Set is intended for use | ||
| in monitoring the quality | ||
| control of results obtained | ||
| with the Diazyme Lipoprotein | ||
| (a) Assay reagents by | ||
| turbidimetry. For in vitro | ||
| diagnostic use only. | ||
| Instrumentation | Hitachi 717 | Olympus AU400 |
| Lp(a) Calibrators | Lyophilized human serum | |
| and plasma | Liquid stable human serum | |
| and plasma | ||
| Calibrator Composition | Human serum, with active | |
| ingredient Lp(a) | Human serum, preservative, | |
| and active ingredient Lp(a) | ||
| Control Composition | Lyophilized human serum | Human serum, preservative, |
| and active ingredient Lp(a) | ||
| Standardization | Using a single lot of predicate | |
| device reagents and calibrator, | ||
| Diazyme Lp(a) master lot of | ||
| calibrator materials were | ||
| assigned values as follows. The | ||
| calibrator materials were assayed | ||
| as samples three times | ||
| in | ||
| triplicate on the Hitachi | ||
| or | ||
| Olympus Analyzer. For each | ||
| calibrator level, mean values | ||
| were calculated from the data | ||
| points and assigned as the | Value Transfer from predicate | |
| device Diazyme Lp(a) Reagent | ||
| and calibrator (K082488) to | ||
| reference lot of liquid stable | ||
| calibrators | ||
| Using predicate device: | ||
| Diazyme Lp(a) Latex Reagent | ||
| and calibrator (K082488). | ||
| Diazyme Lp(a) reference lot | ||
| of liquid stable calibrator | ||
| materials were assigned values | ||
| calibrator value. For each new lot | ||
| of calibrator materials produced, | ||
| the master lot or reference lot | ||
| calibrator is used in conjunction | ||
| with the reference lot of Diazyme | ||
| Lp(a) Assay reagents to test and | ||
| verify calibrator value. | as follows: The calibrator | |
| materials were assayed as | ||
| samples in triplicate on | ||
| Beckman AU400 Analyzer. | ||
| For each calibrator level, | ||
| mean values were calculated | ||
| and assigned as the initial | ||
| calibrator value. |
Lp(a) Liquid Stable Calibrator
Value Verification
Reference lot of the Lp(a) liquid
stable calibrator with the target
values assigned are used to test
library samples assigned with
predicate device and trueness
controls. |
| Calibrator Range | 0-100 mg/dL | 0-100 mg/dL |
| Analytical Sensitivity | 5.44 mg/dL | 5.44 mg/dL |
| LOB | LOB = 1.14 mg/dL | LOB = 1.13 mg/dL |
| LOQ | LOQ = 5.44 mg/dL | LOQ = 5.44 mg/dL
(Sensitivity checked to
confirm previously approved
data) |
| Dynamic Range | Up to 100 mg/dL Lp(a) | Up to 100 mg/dL Lp(a) |
The table below compares the new device, Diazyme Lp(a) Calibrator Set and Control Set, with the predicate device, Diazyme Lp(a) Calibrators and Controls (K082488).
3
Verification/Validation of Modification:
The nonclinical performance of the Diazyme Lp(a) Calibrator Set and Control Set was demonstrated through the following studies:
- . 20-Day Precision
- Limits of Blank/Detection/Quantitation (LOB/LOD/LOQ) .
- . Linearity ·
- Accuracy by Method Comparison .
- Accuracy by Matrix Comparison · .
- . Interference
- Accelerated Calibrator Stability .
- Real Time Calibrator Stability .
- Accelerated Control Stability .
- Real Time Control Stability .
- Open and Closed Vial Calibrator Stability .
- Value Assignment and Traceability .
4
Conclusion:
Current Diazyme Lp(a) Assay reagent and calibrators (K082488) were selected for comparing serum Lp(a) levels to the results generated by the modified device Diazyme Lp(a) Calibrator Set and current Diazyme Lp(a) Assay reagent. The accuracy between the results obtained by Diazyme Lp(a) Assay Kit (K082488) and proposed calibrators and controls (Diazyme Lp(a) Calibrator Set and Control Set) unequivocally demonstrates excellent correlation. As a result, the Lp(a) Calibrator Set and Control Set use for measurement of Lp(a) in patient serum samples is substantially equivalent to legally marketed devices. The differences in the calibrator components (lyophilized versus liquid stable) should not affect the safety and effectiveness of the Diazyme Lp(a) Assay reagents.
In summary, the dissimilar composition features of the Diazyme Lp(a) Calibrator Set and control Set (compared to predicate) do not affect the safety or effectiveness of the Diazyme Lp(a) Assay.
5
Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wing-like shapes extending upwards and to the right.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 26, 2013
Diazyme Laboratories C/O Dr. Abhijit Datta 12889 Gregg Court POWAY CA 92064
Re: K131556
Trade/Device Name: Diazyme Lipoprotein (a) Calibrator Set and Diazyme Lipoprotein (a)
Control Set Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIT, JJX Dated: May 28, 2013 Received: May 29, 2013
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
6
Page 2-Dr. Datta
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Carol C. Benson -S for
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number : K131556
Device Name: Diazyme Lipoprotein (a) Calibrator Set, Diazyme Lipoprotein (a) Control Set
Indications for Use:
The Diazyme Lipoprotein (a) Calibrator Set is intended for use in establishing the calibration curve for the Diazyme Lipoprotein (a) Assay reagents by turbidimetry. For in vitro diagnostic use only.
The Diazyme Lipoprotein (a) Control Set is intended for use in monitoring the quality control of results obtained with the Diazyme Lipoprotein (a) Assay reagents by turbidimetry. For in vitro diagnostic use only.
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 Diagnostics and Radiological Health (OIR)
Ruth A. Chester -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k)_k131556