Aptiva APS IgG Reagent; Aptiva APS IgM Reagent

K223093 · Inova Diagnostics, Inc. · MID · Dec 17, 2024 · Immunology

Device Facts

• Record ID: K223093
• Device Name: Aptiva APS IgG Reagent; Aptiva APS IgM Reagent
• Applicant: Inova Diagnostics, Inc.
• Product Code: MID · Immunology
• Decision Date: Dec 17, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended 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.

Device Story

Aptiva APS IgG/IgM reagents are particle-based multi-analyte (PMAT) immunoassays for automated, random-access analysis on the Aptiva System. Input: human serum samples. Operation: paramagnetic microparticles coated with cardiolipin and beta-2 glycoprotein 1 antigens are rehydrated and incubated with diluted sample; after washing, phycoerythrin-conjugated anti-human IgG or IgM antibodies are added. The system uses an optical module to generate images, identifying unique particle populations and measuring median fluorescent intensity (MFI). Output: semiquantitative results (FLU) calculated via lot-specific master curves stored on RFID. Used in clinical laboratories by trained personnel. Results aid clinicians in diagnosing APS by identifying specific autoantibodies. Benefits include automated, high-throughput, multi-analyte testing compared to manual ELISA methods.

Clinical Evidence

Clinical validation included 526 samples for IgG (122 APS, 404 controls) and 689 samples for IgM (291 APS, 398 controls). For IgG: aCL sensitivity 54.1%, specificity 99.5%; aβ2GPI sensitivity 53.3%, specificity 99.0%. For IgM: aCL sensitivity 27.5%, specificity 97.5%; aβ2GPI sensitivity 24.7%, specificity 98.5%.

Technological Characteristics

Particle-based multi-analyte technology (PMAT) using paramagnetic microparticles. Reagents include cardiolipin and beta-2 glycoprotein 1 antigens, goat anti-human IgG/IgM tracer antibodies labeled with phycoerythrin. Fully automated, random-access analyzer (Aptiva System) with optical module. Connectivity via RFID-tagged reagent cartridges. Software uses 4-parameter logistic (4PL) curve fitting for quantitation.

Indications for Use

Indicated for semiquantitative determination of anti-cardiolipin (aCL) and anti-beta 2 glycoprotein 1 (aß2GPI) IgG/IgM autoantibodies in human serum to aid in the diagnosis of primary and secondary antiphospholipid syndrome (APS) in conjunction with other clinical/laboratory findings.

Regulatory Classification

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).

Predicate Devices

• HemosIL™ AcuStar Anti-Cardiolipin IgG (K092181)
• QUANTA Lite™ Beta 2GP1 IgG ELISA (K970551)
• HemosIL™ AcuStar Anti-Cardiolipin IgM (K092181)
• HemosIL™ AcuStar Anti-ß2 Glycoprotein-I IgM (K091556)

Submission Summary (Full Text)

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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.

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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

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] 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

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#### 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*)

| <div> <span style="font-size: 10pt"> <span style="text-decoration: line-through;">X</span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
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## 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 | |

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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<br>9900 Old Grove Road,<br>San Diego, CA, 92131 |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Purpose of submission: | New device |
| Device in the submission: | Aptiva APS IgG Reagent<br>Aptiva APS IgM Reagent |
| Scientific contact: | Andrea Seaman, Associate Director, Research and Development<br>Inova Diagnostics, Inc.<br>9900 Old Grove Road, San Diego, CA, 92131<br>Phone: [phone] x77395<br>Fax: [phone]<br>Email: [e-mail] |
| Quality Systems contact: | Constance Bridges, VP, Quality and Regulatory<br>Inova Diagnostics, Inc<br>9900 Old Grove Road, San Diego, CA, 92131<br>Phone: [phone] x77212<br>Fax: [phone]<br>Email: [e-mail] |
| Device name (kit): | Proprietary name: Aptiva APS IgG Reagent<br>Aptiva APS IgM Reagent<br>Common name: anti-cardiolipin antibody immunoassay, anti-<br>beta2-glycprotein1 immunoassay<br>Classification name: System, Test, Anticardiolipin Immunological<br>System, Test, Beta2 Glycoprotein1<br>Immunological |
| Regulation Description | Multiple autoantibodies immunological test system |
| Regulation Medical<br>Specialty | Immunology |
| Review Panel | Immunology |
| Product Code | Anticardiolipin: MID<br>B2 - Glycoprotein I: MSV |
| Regulation Number | 866.5660 |
| Device Class | 2 |

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#### 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.

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| Contents | Active Ingredient | Quantity | Symbol |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|--------|
| 1. Aptiva APS IgG Reagent<br>Cartridge | - | 1 each | RC |
| - APS IgG Beads | - Paramagnetic beads coated with:<br>- Native Cardiolipin (CL) plus β2GPI antigens (<0.01%)<br>- Native β2GPI antigen (<0.5%)<br>- AffiniPure Goat polyclonal anti-human IgG antigen (<0.01%)<br>- Bovine protein stabilizer (<2.4%) | 1 x 0.5mL | - |
| - Assay Buffer | - Bovine/porcine protein stabilizer (<0.5%)<br>- Bovine protein stabilizer (<0.3%)<br>- Sodium azide (<0.1%) | 1 x 17mL | - |
| - PE Tracer IgG | - PE IgG Conjugate, Goat anti-human IgG antibody (<0.30%)<br>- Bovine protein stabilizer (<1.2%)<br>- Sodium azide (<0.1%) | 1 x 17mL | - |
| - Rehydration Buffer | - Bovine protein stabilizer (<0.03%)<br>- Sodium azide (<0.1%) | 1 x 6.5mL | - |

The Aptiva APS IgG Reagent kit contains the following materials:

The Aptiva APS IgM Reagent kit contains the following materials:

| | Contents | Active Ingredient | Quantity | Symbol | |
|----|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|--------|--|
| 1. | Aptiva APS IgM Reagent Cartridge | - | 1 each | RC | |
| | - APS IgM Beads | Paramagnetic beads coated with:<br>- Native Cardiolipin (CL) plus β2GPI antigens (<0.01%)<br>- Native β2GPI antigen (<0.04%)<br>- AffiniPure Goat polyclonal anti-human IgM antigen (<0.01%)<br>- Bovine protein stabilizer (<2.4%) | 1 x 0.5mL | | |
| | - Assay Buffer | Bovine/porcine protein stabilizer (<0.42%)<br>- Bovine protein stabilizer (<0.27%)<br>- Sodium azide (<0.1%) | 1 x 17mL | | |
| | - PE Tracer IgM | PE IgG Conjugate, Goat anti-human IgM antibody (<0.15%)<br>- Bovine protein stabilizer (<1.2%)<br>- Sodium azide (<0.1%) | 1 x 17mL | | |
| | - Rehydration Buffer | Bovine protein stabilizer (< 0.02%)<br>- Sodium azide (<0.1%) | 1 x 6.5mL | | |

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#### Intended use(s)

The Aptiva APS IgG Reagent is an immunoassay utilizing particle-based multi-analyte technology for the semi-quantitative determination of anti-cardiolipin (aCL) and anti-beta 2 qlycoprotein 1 (aß2GPI) IgG autoantibodies in human serum as an aid in the diagnosis of primary and secondary antiphospholipid syndrome (APS), when used in conjunction with other laboratory and clinical 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 semi-quantitative determination of anti-cardiolipin (aCL) and anti-beta 2 dlycoprotein 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 and clinical findings.

The Aptiva APS IgM Reagent is intended for use with the Aptiva System.

#### Indications for use

Same as intended use.

#### Substantial equivalence

The Aptiva APS IgG Reagent and the Aptiva APS IgM Reagent have the same intended use and assay principle as the predicate devices.

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#### Comparison to predicate device

#### Aptiva APS IgG Reagent - aCL IgG Comparison to Predicate Device

This table provides a comparative description of the similarities and differences between the subject device, Aptiva APS IgG Reagent, and its predicate device currently marketed as QUANTA Flash aCL IgG Reagent. The QUANTA Flash aCL IgG Reagent is equivalent to the HemosIL AcuStar Anti-Cardiolipin IgG assay (K092181).

| | Subject Device | Predicate Device |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Aptiva APS IgG Reagent<br>(aCL IgG) | QUANTA Flash aCL IgG Reagents<br>(aCL IgG) |
| Trade name | Aptiva APS IgG Reagent | QUANTA Flash aCL IgG Reagents |
| Intended Use /<br>Indication for Use | The Aptiva APS IgG Reagent is an<br>immunoassay utilizing particle-based<br>multi-analyte technology for the semi-<br>quantitative determination of anti-<br>cardiolipin (aCL) and anti-beta 2<br>glycoprotein 1 (aβ2GPI) IgG<br>autoantibodies in human serum as an<br>aid in the diagnosis of primary and<br>secondary antiphospholipid syndrome<br>(APS), when used in conjunction with<br>other laboratory and clinical findings.<br>The Aptiva APS IgG Reagent is<br>intended for use with the Aptiva Multi-<br>Analyte System. | Fully automated chemiluminescent<br>immunoassay for the semi-quantitative<br>measurement of anti-cardiolipin (aCL)<br>IgG antibodies in human citrated<br>plasma and serum on the BIO-FLASH<br>instrument as an aid in the diagnosis of<br>thrombotic disorders related to primary<br>and secondary antiphospholipid<br>syndrome (APS), when used in<br>conjunction with other laboratory and<br>clinical findings. |
| Type of Test | Semi-quantitative | Same |
| Instrument<br>Platform | Aptiva System | BIO-FLASH instrument |
| Technology | Fluorescent immunoassay | Chemiluminescent immunoassay |
| Clinical Cut-off | 5.00 FLU | 20.0 CU* (20 U/mL+) |
| Calibrator | Three Calibrator Levels | Two Calibrator Levels |
| Composition | 1 cartridge containing 1 vial of magnetic<br>particle suspension coated with bovine<br>cardiolipin and human purified β2GPI, 1<br>vial of assay buffer, 1 vial of tracer<br>consisting of an anti-human IgG<br>antibody labeled with phycoerythrin,<br>and 1 vial of sample diluent. | 1 cartridge containing 1 vial of magnetic<br>particle suspension coated with bovine<br>cardiolipin and human purified β2GPI, 1<br>vial of assay buffer, 1 vial of tracer<br>consisting of an anti-human IgG<br>antibody labeled with isoluminol, and 1<br>vial of sample diluent. |
| Sample Type | Serum | Serum or Citrated Plasma |
| Quality Control | Two Control Levels | Same |
| Detection Limit | 0.07 FLU | 2.6 CU* (20 U/mL+) |
| Linearity | 0.29 FLU - 328.94 FLU | 2.6 – 2024 U/mL |

* Applicable to QUANTA Flash aCL IgG Reagent

† Applicable to HemosIL AcuStar Anti-Cardiolipin IgG

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| Aptiva APS IgG Reagent - β2GPI IgG Comparison to Predicate Device | | |
|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| This table provides a comparative description of the similarities and differences between the subject | | |
| device, Aptiva APS IgG Reagent, and its predicate device, the currently marketed QUANTA Lite Beta | | |
| 2GP1 IgG ELISA (K970551). | | |
| Item | Aptiva APS IgG Reagent<br>(ß2GPI IgG) | QUANTA Lite Beta 2GP1 IgG ELISA<br>(aCL IgG) |
| Trade name | Aptiva APS IgG Reagent | QUANTA Lite Beta 2GP1 IgG ELISA |
| Intended Use /<br>Indication for Use | The Aptiva APS IgG Reagent is an<br>immunoassay utilizing particle-<br>based multi-analyte technology for<br>the semi-quantitative determination<br>of anti-cardiolipin (aCL) and anti-<br>beta 2 glycoprotein 1 (aß2GPI) IgG<br>autoantibodies in human serum as<br>an aid in the diagnosis of primary<br>and secondary antiphospholipid<br>syndrome (APS), when used in<br>conjunction with other laboratory<br>and clinical findings.<br>The Aptiva APS IgG Reagent is<br>intended for use with the Aptiva<br>Multi-Analyte System. | QUANTA Lite Beta 2GP1 IgG is an<br>enzyme-linked immunosorbent assay<br>(ELISA) for the semi-quantitative<br>detection of ß2 GPI IgG antibodies in<br>human serum. The presence of ß2<br>GPI IgG antibodies can be used in<br>conjunction with clinical findings and<br>other laboratory tests to aid in the<br>diagnosis of certain autoimmune<br>disease thrombotic disorders, such as<br>those secondary to systemic lupus<br>erythematosus (SLE) or other lupus-<br>like thrombotic diseases. |
| Type of Test | Semi-quantitative | Same |
| Instrument Platform | Aptiva Multi-Analyte System | N/A - manually run assay |
| Technology | Fluorescent immunoassay | Enzyme-linked immunosorbent assay |
| Clinical Cut-off | 5.00 FLU | 20.0 SGU |
| Calibrator | Three Calibrator Levels | Five Calibrator Levels |
| Composition | 1 cartridge containing 1 vial of<br>magnetic particle suspension<br>coated with bovine cardiolipin and<br>human purified ß2GPI, 1 vial of<br>assay buffer, 1 vial of tracer<br>consisting of an anti-human IgG<br>antibody labeled with phycoerythrin,<br>and 1 vial of sample diluent. | Kit contains 1 β2 GPI ELISA Plate<br>(12-1 x 8 wells), 1 vial prediluted<br>ELISA Negative Control, 1 vial<br>prediluted ß2 GPI IgG ELISA Control,<br>5 vials prediluted β2 GPI IgG ELISA<br>Calibrators, 1 vial HRP Sample<br>Diluent, 1 vial HRP Wash<br>Concentrate (40x), 1 vial HRP IgG<br>Conjugate, (goat), anti-human IgG, 1<br>vial 10mL TMB Chromogen, and 1<br>vial HRP Stop Solution |
| Sample Type | Serum | Same |
| Quality Control | Two Control Levels | Two Controls - one positive and one<br>negative |
| Linearity | 0.21 - 256.70 FLU | 9.4 - 150.0 SGU |

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| Aptiva APS IgM Reagent - aCL IgM Comparison to Predicate Device | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| This table provides a comparative description of the similarities and differences between the subject device, Aptiva APS IgM Reagent, and its predicate device currently marketed QUANTA Flash aCL IgM Reagent. The QUANTA Flash aCL IgM Reagent is equivalent to the HemosIL AcuStar Anti-Cardiolipin IgM assay (K092181). | | |
| Item | Aptiva APS IgM Reagent (aCL IgM) | QUANTA Flash aCL IgG Reagents (aCL IgM) |
| Trade name | Aptiva APS IgM Reagent | QUANTA Flash aCL IgM Reagents |
| Intended Use /<br>Indication for Use | The Aptiva APS IgM Reagent is an immunoassay utilizing particle-based multi-analyte technology for the semi-quantitative determination of anti-cardiolipin (aCL) and anti-beta 2 glycoprotein 1 (aβ2GPI) 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 and clinical findings.<br><br>The Aptiva APS IgM Reagent is intended for use with the Aptiva Multi-Analyte System. | Fully automated chemiluminescent immunoassay for the semi-quantitative measurement of anti-cardiolipin (aCL) IgG antibodies in human citrated plasma and serum on the BIO-FLASH instrument as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome (APS), when used in conjunction with other laboratory and clinical findings. |
| Type of Test | Semi-quantitative | Same |
| Instrument<br>Platform | Aptiva Multi-Analyte System | BIO-FLASH instrument |
| Technology | Fluorescent immunoassay | Chemiluminescent immunoassay |
| Clinical Cut-off | 5.00 FLU | 20.0 CU* (20U/mL†) |
| Calibrator | Three Calibrator Levels | Two Calibrator Levels |
| Composition | 1 cartridge containing 1 vial of magnetic particle suspension coated with bovine cardiolipin and human purified β2GPI, 1 vial of assay buffer, 1 vial of tracer consisting of an anti-human IgM antibody labeled with phycoerythrin, and 1 vial of sample diluent. | 1 cartridge containing 1 vial of magnetic particle suspension coated with bovine cardiolipin and human purified β2GPI, 1 vial of assay buffer, 1 vial of tracer consisting of an anti-human IgM antibody labeled with isoluminol, and 1 vial of sample diluent. |
| Sample Type | Serum | Serum or Citrated Plasma |
| Quality Control | Two Control Levels | Two Control Levels I |
| Detection Limit | 0.04 FLU | 1.0 CU* (1 U/mL+) |
| Linearity | 0.10 FLU - 114.68 FLU | 1.0 - 774 CU* (1.0 - 774 U/mL+) |
| Item…