(809 days)
Not Found
No
The description details standard immunoassay technology and automated analysis, without mentioning AI or ML algorithms for data processing or interpretation.
No
The device is an immunoassay designed for diagnostic purposes, specifically for the semiquantitative determination of autoantibodies as an aid in diagnosing antiphospholipid syndrome (APS), rather than providing therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an aid in the diagnosis of primary antiphospholipid syndrome (APS)".
No
The device is described as a fully automated, random-access analyzer (Aptiva instrument) that includes liquid handling hardware, an optical module, and an integrated computer with software. This clearly indicates the presence of significant hardware components beyond just software.
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 reagents are for the "semiquantitative determination of anti-cardiolipin (aCL) and anti-beta 2 glycoprotein 1 (aß2GPI) IgG/IgM autoantibodies in human serum as an aid in the diagnosis of primary and secondary antiphospholipid syndrome (APS), when used in conjunction with other laboratory findings." This clearly indicates the device is intended for use on samples taken from the human body to provide information for diagnostic purposes.
- Sample Type: The device uses "human serum," which is a biological sample taken from the human body.
- Purpose: The purpose is to aid in the diagnosis of a medical condition (antiphospholipid syndrome).
- Device Description: The description details an immunoassay process performed on the human serum sample using reagents and an automated instrument. This is characteristic of an in vitro diagnostic test.
- Performance Studies: The document includes extensive performance studies (analytical and clinical) demonstrating the device's ability to accurately measure the target analytes in human samples and its clinical utility in aiding diagnosis.
All these points align with the definition of an In Vitro Diagnostic device.
N/A
#_Intended Use / Indications for Use
The Aptiva APS IgG Reagent is an immunoassay utilizing particle-based multi-analyte technology for the semiquantitative determination of anti-cardiolipin (aCL) and anti-beta 2 glycoprotein 1 (aß2GPI) IgG autoantibodies in human serum as an aid in the diagnosis of primary antiphospholipid syndrome (APS), when used in conjunction with other laboratory findings.
The Aptiva APS IgG Reagent is intended for use with the Aptiva System.
The Aptiva APS IgM Reagent is an immunoassay utilizing particle-based multi-analyte technology for the semiquantitative determination of anti-cardiolipin (aCL) and anti-beta 2 glycoprotein 1 (aß2GPI) IgM autoantibodies in human serum as an aid in the diagnosis of primary and secondary antiphospholipid syndrome (APS), when used in conjunction with other laboratory findings.
The Aptiva APS IgM Reagent is intended for use with the Aptiva System.
Product codes (comma separated list FDA assigned to the subject device)
MID, MSV
Device Description
The Aptiva APS IgG and Aptiva APS IgM reagent utilize particle based multi-analyte technology (PMAT) in a cartridge format. Each analyte (anti-cardiolipin [aCL] and anti-B2-Glycoprotein I [aB2GPI]) in the Aptiva APS IgG and Aptiva APS IgM reagent is a solid phase immunoassay utilizing fluorescent microparticles. This technology allows each of the two analytes, along with a human IgG or human IgM capture antibody (IgG or IgM Control Microparticle), to be coated onto three uniquely recognizable paramagnetic microparticles, which are combined into one tube.
The Aptiva instrument is a fully automated, random-access analyzer. This platform is a closed system with continuous load and random-access capabilities that processes the samples, runs the reagent and reports results. It includes liquid handling hardware, optical module (OM), and integrated computer with proprietary software and touch screen user interface.
The two analyte microparticles, along with the control microparticle, are stored in the reagent cartridge under conditions that proteins in their reactive states. When the assay cartridge is ready to be used for the first time, the reagent tube seals are pierced using the cartridge lid. The reagent cartridge is then loaded onto the Aptiva instrument, where the microparticles are automatically rehydrated using a buffer located within the cartridge.
The Aptiva System dilutes the sample 1:8, then combines an aliquot of diluted sample, and reagent into a cuyette. The mixture is incubated at 37°C. After a wash cvcle, conjugated antihuman IgG or IdM antibodies are added to the particles and this mixture is incubated at 37°C. Excess conjugate is removed in another wash cycle, and the particles are re-suspended in system fluid.
Multiple images are generated by the system to identify and count the two (2) unique analyte particles, as well as determine the amount of coniugate on each particle. Coated with goat anti-human lgG or IdM antibodies, is present as a control to flaq low concentrations of IgG or IgM in the sample as an assay verification step. The median fluorescent intensity (MFI) for each analyte is proportional to the concentration of conjugate bound to human IgG or IgM, which is proportional to the concentration of IgG or IgM antibodies bound to the corresponding particle population. The system uses the MFI from at least 50 particles of each population. The identity of the particles is determined by the unique signature of the particles.
Each analyte in the Aptiva APS IgG Reagent and the Aptiva APS IgM Reagent is assigned a predefined lot specific master curve. The analyte specific master curve is stored on the reagent cartridge RFID label. Based on results obtained by running calibrators (supplied separately), the system creates individual working curves. Working curves are used by the software to calculate Fluorescent Light Units (FLU) for each analyte from the MFI values obtained for each sample.
Aptiva APS IgG and Aptiva APS IgM Calibrators and Aptiva APS IgG and Aptiva APS IgM Controls are sold separately.
Mentions image processing
Multiple images are generated by the system to identify and count the two (2) unique analyte particles, as well as determine the amount of coniugate on each particle.
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
A cohort of characterized samples, none of which were used for establishing the reference range, was used to validate the clinical performance of the Aptiva APS IgG and Aptiva APS IgM Reagents.
For Aptiva APS IgG, a total of 526 characterized samples were included in this validation set, including 60 patients with primary antiphospholipid syndrome and 62 patients with secondary antiphospholipid syndrome (pAPS and sAPS) and 404 control samples from patients with various types of autoimmune and infectious diseases. All samples were run on the Aptiva APS IgG Reagent.
For Aptiva APS IgM, a total of 689 characterized samples were included in this validation set, including 291 samples from APS patients and 398 control samples from patients with various types of autoimmune and infectious diseases. All samples were run on the Aptiva APS IgM Reagent.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Precision Study: The precision of the Aptiva APS IgG and Aptiva APS IgM reagents was evaluated on seven samples for aCL IgG, aB2GPI IgG, aCL IgM and a82GPI IgM, containing various concentrations of antibodies in accordance with CLSI EP05-A3, Evaluation of Quantitative Measurement Procedures; Approved Guideline. Samples were run in duplicates, twice a day, for 20 days.
- Reproducibility Studies (between sites): Seven samples for aCL IgG and aß2GPI IgG and six samples for aCL IgM and aβ2GPI IgM were tested according to CLSI EP05-A3 Evaluation of Quantitative Measurement Procedures; Approved Guideline, at three different sites. Samples were run in replicates of five, once a day, for five days, to generate 25 data points per site.
- Reproducibility Studies (between lots): Seven samples for aCL IgG and aß2GPI IgG and six samples for aCL IgM and aß2GPI IgM were tested according to CLSI EP05-A3 Evaluation of Quantitative Measurement Procedures; Approved Guideline, using three different lots. Samples were run in replicates of 5, once a day, for 5 days, to generate 25 data points per sample, per lot, 75 data points total for each sample.
- LoB, LoD, and LoQ Study: The LoB, LoD, and LoQ of the aCL IgG, aß2GPI IgG, aCL IgM and aβ2GPI IgM assays in the Aptiva APS IgG and Aptiva APS IgM Reagent were calculated separately by a study according to CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline- Second Edition. For LoB: Four blank samples were run in replicates of five on two reagent lots, once per day, for 3 days, with 60 data points generated on each lot. For LoD: Four low level samples were run in replicates of five on two reagent lots, twice per day, for 3 days, with 120 data points generated on each assay, on each reagent lot. For LoQ: Four low level samples were run in replicates of five on two reagent lots, twice per day, for 3 days, with 120 data points generated on each assay, on each reagent lot.
- High concentration hook effect: 2 samples aCL IgG, aß2GPI IgG, aCL IgM and aβ2GPI IgM assays were tested at increasing 2-fold serial dilutions from the standard 1:8 dilution used by the Aptiva APS IgG and Aptiva APS IgM Reagents.
- Linearity Study: The linearity of the AMR of Aptiva APS IgM and Aptiva APS IgG was evaluated by a study according to CLSI EP06, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline. Five human serum samples for Aptiva APS IgG and four human serum samples for Aptiva APS IgM with various antibody concentrations were serially diluted to obtain values that cover the entire AMR. The dilutions were assayed in duplicates.
- Interference Study: The interference study was performed according to CLSI EP07-A2, Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition. Six human specimens, a set of three human serum samples (one positive, one around the cutoff and one negative sample) were tested. Endogenous and exogenous substances were spiked into each specimen and the resulting samples were assessed in five replicates.
- Sample Stability and Handling: Five serum samples were tested for aCL IgG, aB2GPI IgG, aCL IgM and a82GPI IgM. Samples were tested in duplicates for up to 21 days (2-8°C), up to 49 hours (room temperature), and after up to 6 freeze/thaw cycles.
- Reagent Stability (Shelf life): Real-time stability (on-going) and accelerated stability studies were performed to establish the initial claim for shelf life for the Aptiva APS IgG and the Aptiva APS IgM Reagents. Accelerated studies were performed on three lots for 5 weeks at 37°C ± 3°C.
- Reagent Stability (In-use/onboard): One lot of reagents was tested using 11 samples for IgG and seven samples for IgM. Specimens were tested periodically for 33 days for IgG and 37 days for IgM.
- Cut-off, reference range: The reference population for establishing the cutoff values for the aCL IgG and aß2GPI IgG assays in the Aptiva APS IgG Reagent consisted of 52 apparently healthy subjects and for the aCL IgM and aß2GPI IgM assays in the Aptiva APS IgM Reagent 54 apparently healthy subjects. The cut-off was established based on greater than the 99th percentile of the results obtained on the reference healthy population.
- Clinical Performance (Sensitivity, Specificity): For Aptiva APS IgG, a total of 526 characterized samples were included (122 APS patients, 404 controls). For Aptiva APS IgM, a total of 689 characterized samples (291 APS patients, 398 controls).
- Expected Values: A panel of 200 apparently healthy blood donors were tested on the Aptiva APS IgG and Aptiva APS IgM Reagent.
- Comparison with predicate device: For Aptiva APS IgG, samples for method comparison analysis included all samples from the clinical validation study that display results within the analytical measuring range of the assay and its predicate device (N=202 for aCL IgG, N=108 for aß2GPI IgG). For Aptiva APS IgM, samples included all samples from the clinical validation study that display results within the analytical measuring range of the assay and its predicate device (N=422 for aCL IgM, N=244 for aß2GPI IgM).
Key Results:
- Analytical Measuring Range (AMR):
- Aptiva APG IgG Reagent:
- aCL IgG: 0.29 - 328.94 FLU
- aβ2GPI IgG: 0.21 - 256.70 FLU
- Aptiva APG IgM Reagent:
- aCL IgM: 0.10 – 114.68 FLU
- aβ2GPI IgM: 0.10 – 95.86 FLU
- Aptiva APG IgG Reagent:
- High concentration hook effect: No hook effect detected up to 2645.36 FLU for aCL lgG, 1790.48 FLU for a82GPI IgG, 167.25 FLU for aCL IgM and 126.13 FLU for the aβ2GPI IgM (theoretical values calculated).
- Linearity: Data demonstrate linearity of the analytical measuring range for all analytes.
- Interference: No interference detected for aCL IgG, aß2GPI IgG, aCL IgM and aβ2GPI IgM with all tested endogenous and exogenous substances within tested concentrations.
- Sample Stability: Samples may be stored up to 48 hours at room temperature, up to 14 days at 2-8°C and can be subjected to up to 5 freeze/thaw cycles.
- Reagent Stability (Shelf life): Shelf-life of nine months for Aptiva APS IgG Reagent and seven months for Aptiva APS IgM Reagent.
- Reagent Stability (In-use/onboard): In-use (onboard) stability of 28 days, with a 14-day recalibration.
- Cut-off: 5.00 FLU for all assays.
- Clinical Sensitivity/Specificity:
- Aptiva APS IgG (aCL IgG): Sensitivity 54.1% (45.3 – 62.7%), Specificity 99.5% (98.2 – 99.9%)
- Aptiva APS IgG (aß2GPI IgG): Sensitivity 53.3% (44.5-61.9%), Specificity 99.0% (97.5-99.6%)
- Aptiva APS IgM (aCL IgM): Sensitivity 27.5% (22.7 – 32.9%), Specificity 97.5% (95.4 – 98.6%)
- Aptiva APS IgM (a82GPI IgM): Sensitivity 24.7% (20.1 – 30.0%), Specificity 98.5% (96.8 – 99.3%)
- Expected values: In a panel of 200 healthy blood donors, no samples were positive for any analytes using the 5.00 FLU cut-off.
- Method Comparison with Predicate Device (Percent Agreement):
- Aptiva APS IgG (aCL IgG) vs. QUANTA Flash aCL IgG: PPA: 81.6% (66.6-90.8%), NPA: 95.7% (91.5-97.9%), TPA: 93.1% (88.7-95.8%)
- Aptiva APS IgG (aß2GPI IgG) vs. QUANTA Lite Beta 2GP1 IgG ELISA: PPA: 88.0% (76.2-94.4%), NPA: 89.7% (79.2-95.2%), TPA: 88.9% (81.6-93.5%)
- Aptiva APS IgM (aCL IgM) vs. QUANTA Flash aCL IgM: PPA: 87.0% (74.3-93.9%), NPA: 90.2% (86.7-92.8%), TPA: 89.8% (86.6-92.3%)
- Aptiva APS IgM (aß2GPI IgM) vs. QUANTA Flash ß2GPI IgM: PPA: 88.9% (71.9-96.1%), NPA: 84.3% (78.9-88.6%), TPA: 84.8% (79.8-88.8%)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
-
Sensitivity:
- Aptiva APS IgG (aCL IgG): 54.1% (45.3 – 62.7%)
- Aptiva APS IgG (aß2GPI IgG): 53.3 % (44.5-61.9%)
- Aptiva APS IgM (aCL IgM): 27.5% (22.7 – 32.9%)
- Aptiva APS IgM (a82GPI IgM): 24.7% (20.1 – 30.0%)
-
Specificity:
- Aptiva APS IgG (aCL IgG): 99.5% (98.2 – 99.9%)
- Aptiva APS IgG (aß2GPI IgG): 99.0% (97.5-99.6%)
- Aptiva APS IgM (aCL IgM): 97.5% (95.4 – 98.6%)
- Aptiva APS IgM (a82GPI IgM): 98.5% (96.8 – 99.3%)
-
Method Comparison Percent Agreement:
- Aptiva APS IgG (aCL IgG) vs. QUANTA Flash aCL IgG:
- PPA: 81.6% (66.6-90.8%)
- NPA: 95.7% (91.5-97.9%)
- TPA: 93.1% (88.7-95.8%)
- Aptiva APS IgG (aß2GPI IgG) vs. QUANTA Lite Beta 2GP1 IgG ELISA:
- PPA: 88.0% (76.2-94.4%)
- NPA: 89.7% (79.2-95.2%)
- TPA: 88.9% (81.6-93.5%)
- Aptiva APS IgM (aCL IgM) vs. QUANTA Flash aCL IgM:
- PPA: 87.0% (74.3-93.9%)
- NPA: 90.2% (86.7-92.8%)
- TPA: 89.8% (86.6-92.3%)
- Aptiva APS IgM (aß2GPI IgM) vs. QUANTA Flash ß2GPI IgM:
- PPA: 88.9% (71.9-96.1%)
- NPA: 84.3% (78.9-88.6%)
- TPA: 84.8% (79.8-88.8%)
- Aptiva APS IgG (aCL IgG) vs. QUANTA Flash aCL IgG:
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
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 17, 2024
Inova Diagnostics, Inc. Constance Bridges VP, Quality & Regulatory Affairs 9900 Old Grove Road San Diego, California 92131
Re: K223093
Trade/Device Name: Aptiva APS IgG Reagent Aptiva APS IgM Reagent Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple Autoantibodies Immunological Test System Regulatory Class: Class II Product Code: MID, MSV Dated: December 14, 2023 Received: December 15, 2023
Dear Constance Bridges:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ying Mao -S
Ying Mao, Ph.D. Branch Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K223093
Device Name Aptiva APS IgG Reagent Aptiva APS IgM Reagent
Indications for Use (Describe)
The Aptiva APS IgG Reagent is an immunoassay utilizing particle-based multi-analyte technology for the semiquantitative determination of anti-cardiolipin (aCL) and anti-beta 2 glycoprotein 1 (all2GPI) IgG autoantibodies in human serum as an aid in the diagnosis of primary antiphospholipid syndrome (APS), when used in conjunction with other laboratory findings.
The Aptiva APS IgG Reagent is intended for use with the Aptiva System.
The Aptiva APS IgM Reagent is an immunoassay utilizing particle-based multi-analyte technology for the semiquantitative determination of anti-cardiolipin (aCL) and anti-beta 2 glycoprotein 1 (aß2GPI) IgM autoantibodies in human serum as an aid in the diagnosis of primary and secondary antiphospholipid syndrome (APS), when used in conjunction with other laboratory findings.
The Aptiva APS IgM Reagent is intended for use with the Aptiva System.
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995#### DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/0 description: The image shows the logo for Inova Diagnostics, a Werfen Company. The logo consists of a red and blue graphic to the left of the company name. The text "Inova Diagnostics" is in a sans-serif font, with "A Werfen Company" in a smaller font below.
510(k) Summary
Aptiva APS IgG and IgM Reagent
Table of Contents Adminietrotiv dott
| Administrative data | |
|---|---|
| Predicate device | |
| Device description | |
| Intended use(s) | |
| lndications for use | |
| Substantial equivalence | |
| Comparison to predicate device | |
| Analytical performance characteristics | |
| Quantitation and units of measure | |
| Reproducibility Studies | |
| Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ) | |
| Analytical Measuring Range (AMR) | |
| High concentration hook effect | |
| Linearity | |
| Interference | |
| Sample Stability and Handling | |
| Reagent Stability | |
| Cut-off, reference range | |
| Clinical performance characteristics | |
| Clinical sensitivity, specificity | |
| Expected values | |
| Comparison with predicate device |
5
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Administrative data
| Submitter: | Inova Diagnostics, Inc
9900 Old Grove Road,
San Diego, CA, 92131 |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Purpose of submission: | New device |
| Device in the submission: | Aptiva APS IgG Reagent
Aptiva APS IgM Reagent |
| Scientific contact: | Andrea Seaman, Associate Director, Research and Development
Inova Diagnostics, Inc.
9900 Old Grove Road, San Diego, CA, 92131
Phone: 858-586-9900 x77395
Fax: 858-863-0025
Email: aseaman@werfen.com |
| Quality Systems contact: | Constance Bridges, VP, Quality and Regulatory
Inova Diagnostics, Inc
9900 Old Grove Road, San Diego, CA, 92131
Phone: 858-586-9900 x77212
Fax: 858-863-0025
Email: cbridges@werfen.com |
| Device name (kit): | Proprietary name: Aptiva APS IgG Reagent
Aptiva APS IgM Reagent
Common name: anti-cardiolipin antibody immunoassay, anti-
beta2-glycprotein1 immunoassay
Classification name: System, Test, Anticardiolipin Immunological
System, Test, Beta2 Glycoprotein1
Immunological |
| Regulation Description | Multiple autoantibodies immunological test system |
| Regulation Medical
Specialty | Immunology |
| Review Panel | Immunology |
| Product Code | Anticardiolipin: MID
B2 - Glycoprotein I: MSV |
| Regulation Number | 866.5660 |
| Device Class | 2 |
6
Predicate device
HemosIL™ AcuStar Anti-Cardiolipin IgG, 510(k) number: K092181 QUANTA Lite™ Beta 2GP1 IgG ELISA, 510(k) number: K970551 HemosIL™ AcuStar Anti-Cardiolipin IgM, 510(k) number: K092181 HemosIL™ AcuStar Anti-ß2 Glycoprotein-I IgM, 510(k) number: K091556
Device description
The Aptiva APS IgG and Aptiva APS IgM reagent utilize particle based multi-analyte technology (PMAT) in a cartridge format. Each analyte (anti-cardiolipin [aCL] and anti-B2-Glycoprotein I [aB2GPI]) in the Aptiva APS IgG and Aptiva APS IgM reagent is a solid phase immunoassay utilizing fluorescent microparticles. This technology allows each of the two analytes, along with a human IgG or human IgM capture antibody (IgG or IgM Control Microparticle), to be coated onto three uniquely recognizable paramagnetic microparticles, which are combined into one tube.
The Aptiva instrument is a fully automated, random-access analyzer. This platform is a closed system with continuous load and random-access capabilities that processes the samples, runs the reagent and reports results. It includes liquid handling hardware, optical module (OM), and integrated computer with proprietary software and touch screen user interface.
The two analyte microparticles, along with the control microparticle, are stored in the reagent cartridge under conditions that proteins in their reactive states. When the assay cartridge is ready to be used for the first time, the reagent tube seals are pierced using the cartridge lid. The reagent cartridge is then loaded onto the Aptiva instrument, where the microparticles are automatically rehydrated using a buffer located within the cartridge.
The Aptiva System dilutes the sample 1:8, then combines an aliquot of diluted sample, and reagent into a cuyette. The mixture is incubated at 37°C. After a wash cvcle, conjugated antihuman IgG or IdM antibodies are added to the particles and this mixture is incubated at 37°C. Excess conjugate is removed in another wash cycle, and the particles are re-suspended in system fluid.
Multiple images are generated by the system to identify and count the two (2) unique analyte particles, as well as determine the amount of coniugate on each particle. Coated with goat anti-human lgG or IdM antibodies, is present as a control to flaq low concentrations of IgG or IgM in the sample as an assay verification step. The median fluorescent intensity (MFI) for each analyte is proportional to the concentration of conjugate bound to human IgG or IgM, which is proportional to the concentration of IgG or IgM antibodies bound to the corresponding particle population. The system uses the MFI from at least 50 particles of each population. The identity of the particles is determined by the unique signature of the particles.
Each analyte in the Aptiva APS IgG Reagent and the Aptiva APS IgM Reagent is assigned a predefined lot specific master curve. The analyte specific master curve is stored on the reagent cartridge RFID label. Based on results obtained by running calibrators (supplied separately), the system creates individual working curves. Working curves are used by the software to calculate Fluorescent Light Units (FLU) for each analyte from the MFI values obtained for each sample.
Aptiva APS IgG and Aptiva APS IgM Calibrators and Aptiva APS IgG and Aptiva APS IgM Controls are sold separately.
7
Page 4 of 28
| Contents | Active Ingredient | Quantity | Symbol |
|---|---|---|---|
| 1. Aptiva APS IgG Reagent | |||
| Cartridge | - | 1 each | RC |
| - APS IgG Beads | - Paramagnetic beads coated with: |
- Native Cardiolipin (CL) plus β2GPI antigens (