← Product Code [LLL](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LLL) · K213403 # Aptiva CTD Essential Reagent (K213403) _Inova Diagnostics, Inc. · LLL · Sep 29, 2023 · Immunology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LLL/K213403 ## Device Facts - **Applicant:** Inova Diagnostics, Inc. - **Product Code:** [LLL](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LLL.md) - **Decision Date:** Sep 29, 2023 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.5100 - **Device Class:** Class 2 - **Review Panel:** Immunology ## Intended Use The Aptiva CTD Essential Reagent consists of 10 multiplexed immunoassays utilizing particle-based multi-analyte technology for the quantitative determination of IgG autoantibodies against dsDNA, and semi-quantitative determination of IgG autoantibodies against RNP, Sm, Ro52, Ro60, SS-B, Scl-70, Jo-1, centromere, and Ribo-P in human serum: The presence of dsDNA antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of systemic lupus erythematosus. The presence of RNP antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of mixed connective tissue disease and systemic lupus erythematosus. The presence of Sm antibodies, in conjunction with clinical findings and other laboratory tests, is an ad in the diagnosis of systemic lupus erythematosus. The presence of Ro52 antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of systemic lupus erythematosus, Sjögren's systemic scleross, and idiopathic inflammatory myositis. The presence of Ro60 antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of systemic lupus erythematosus and Sjögren's syndrome. The presence of SS-B antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of systemic lupus erythematosus and Sjögren's syndrome. The presence of Scl-70 antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of systemic sclerosis. The presence of Jo-1 antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of idiopathic inflammatory myositis. The presence of centromere antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of systemic sclerosis. The presence of Ribo-P antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of systemic lupus erythematosus. The individual assays included in the Aptiva CTD Essential Reagent are intended for use with the Inova Diagnostics Aptiva System. ## Device Story Aptiva CTD Essential Reagent is a multiplexed immunoassay kit for 10 autoantibodies (dsDNA, RNP, Sm, Ro52, Ro60, SS-B, Scl-70, Jo-1, centromere, Ribo-P) in human serum. Used on the automated Aptiva Multi-Analyte Instrument; utilizes paramagnetic microparticles coated with specific antigens. Patient serum is diluted, incubated with microparticles, and washed; PE-labeled anti-human IgG tracer is added. Instrument optical module uses a CCD camera to image and count microparticle regions; median fluorescent intensity (MFI) is measured. Results are calculated via lot-specific Master Curves (4PL) stored on RFID tags. Provides quantitative (dsDNA) or semi-quantitative (others) results to clinicians to aid in diagnosing connective tissue diseases. Benefits include automated, high-throughput, multiplexed testing, reducing manual labor and improving diagnostic efficiency. ## Clinical Evidence Clinical validation study included 1269 samples from patients with Sjögren's syndrome, SLE, systemic sclerosis, MCTD, IIM, and various controls. Sensitivity and specificity were calculated for each analyte. For example, dsDNA sensitivity 50.4%, specificity 90.1%; Sm sensitivity 10.4%, specificity 99.6%; Centromere sensitivity 47.0%, specificity 97.0%. Performance metrics demonstrate clinical utility as an aid in diagnosis. ## Technological Characteristics Multiplexed particle-based multi-analyte technology (PMAT). Uses 11 paramagnetic microparticle populations (10 analytes + 1 IgG control). Detection via phycoerythrin (PE) tracer and CCD camera imaging. Automated system with RFID-based lot-specific calibration. Software uses 4-parameter logistic (4PL) regression for quantitation. ## Regulatory Identification An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues). ## Predicate Devices - QUANTA Flash® dsDNA IgG ([K152013](/device/K152013.md)) - QUANTA Flash® RNP ([K123593](/device/K123593.md)) - Orgentec Sm ELISA ([K954830](/device/K954830.md)) - QUANTA Flash® Ro52 ([K141655](/device/K141655.md)) - QUANTA Flash® Ro60 ([K141328](/device/K141328.md)) - QUANTA Flash® SS-B ([K141210](/device/K141210.md)) - QUANTA Flash® Scl-70 ([K152635](/device/K152635.md)) - QUANTA Flash® Jo-1 ([K151429](/device/K151429.md)) - QUANTA Flash® Centromere ([K123880](/device/K123880.md)) - QUANTA Lite® Ribo-P ([K981237](/device/K981237.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. September 29, 2023 Inova Diagnostics, Inc. Andrea Seaman Manager, Research and Development 9900 Old Grove Road San Diego, California 92131 Re: K213403 Trade/Device Name: Aptiva CTD Essential Reagent Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear Antibody Immunological Test System Regulatory Class: Class II Product Code: LLL, LJM, LKP, LKO, LSW, MQA, OBE, Dated: February 24, 2023 Received: February 24, 2023 Dear Andrea Seaman: 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. 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 located 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. 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 {1}------------------------------------------------ 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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 mediation-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-regulatoryassistance/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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K213403 Device Name Aptiva CTD Essential Reagents #### Indications for Use (Describe) The Aptiva CTD Essential Reagent consists of 10 multiplexed immunoassays utilizing particle-based multi-analyte technology for the quantitative determination of IgG autoantibodies against dsDNA, and semi-quantitative determination of IgG autoantibodies against RNP, Sm, Ro52, Ro60, SS-B, Scl-70, Jo-1, centromere, and Ribo-P in human serum: · The presence of dsDNA antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of systemic lupus erythematosus. · The presence of RNP antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of mixed connective tissue disease and systemic lupus erythematosus. · The presence of Sm antibodies, in conjunction with clinical findings and other laboratory tests, is an ad in the diagnosis of systemic lupus erythematosus. · The presence of Ro52 antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of systemic lupus erythematosus, Sjögren's systemic scleross, and idiopathic inflammatory myositis. · The presence of Ro60 antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of systemic lupus erythematosus and Sjögren's syndrome. · The presence of SS-B antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of systemic lupus erythematosus and Sjögren's syndrome. · The presence of Scl-70 antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of systemic sclerosis. · The presence of Jo-1 antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of idiopathic inflammatory myositis. · The presence of centromere antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of systemic sclerosis. · The presence of Ribo-P antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of systemic lupus erythematosus. The individual assays included in the Aptiva CTD Essential Reagent are intended for use with the Inova Diagnostics 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. {3}------------------------------------------------ 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 CTD Essential Reagent | Table of Contents | | |----------------------------------------------------------------------------------|----| | Administrative data. | 2 | | Predicate device. | 3 | | Device description. | 3 | | Intended use(s) | 4 | | Indications for use. | 4 | | Substantial equivalence | 5 | | Comparison to predicate device | 5 | | Analytical performance characteristics | 19 | | Quantitation and units of measure. | 19 | | Precision | 21 | | Reproducibility Studies. | 25 | | Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ). | 30 | | Analytical Measuring Range (AMR) | 32 | | Auto-rerun function and reportable results | 32 | | High concentration hook effect. | 32 | | Linearity | 33 | | Interference. | 36 | | Sample Stability and Handling | 36 | | Reagent Stability. | 37 | | Cut-off, reference range | 38 | | Clinical performance characteristics. | 40 | | Clinical sensitivity, specificity | 40 | | Expected values. | 51 | | Comparison with predicate device | 51 | {5}------------------------------------------------ Page 2 of 53 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 CTD Essential 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 Systems and RA
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 CTD Essential Reagent
Common name: anti-nuclear antibody tests
Classification name: Anti-nuclear antibody immunological test system | | Regulation Medical Specialty | Immunology | | Review Panel | Immunology | | Product Code | LLL, Extractable Antinuclear antibody
OBE, Anti-SS-A 52 Autoantibodies
LKP, Anti-Sm antibody
LKO, Anti-RNP Antibody
LJM, Antinuclear Antibody
MQA, Anti-Ribosomal P Antibodies
LSW, Anti-DNA Antibody | | Regulation Number | 866.5100 | | Device Class | 2 | {6}------------------------------------------------ ### Predicate device QUANTA Flash® dsDNA IgG, 510(k) number: K152013. Date declared: April 11, 2016. QUANTA Flash® RNP, 510(k) number: K123593. Date declared: April 17, 2013. Orgentec Sm ELISA, 510(k) number: K954830. Date declared: May 8, 1996. QUANTA Flash® Ro52, 510(k) number: K141655. Date declared: March 5, 2015. QUANTA Flash® Ro60, 510(k) number: K141328. Date declared: February 12, 2015. QUANTA Flash® SS-B, 510(k) number: K141210. Date declared: January 29, 2015. QUANTA Flash® Scl-70, 510(k) number: K152635. Date declared: June 1, 2016. QUANTA Flash® Jo-1, 510(k) number: K151429. Date declared: February 12, 2016. QUANTA Flash® Centromere, 510(k) number: K123880. Date declared: February 7, 2014. QUANTA Lite® Ribo-P, 510(k) number: K981237. Date declared: June 5, 1998. #### Device description The Aptiva CTD Essential reagent utilizes particle based multi-analyte technology (PMAT) in a cartridge format. Each analyte (dsDNA, RNP, Sm, Ro60, Ro52, SS-B, Scl-70, Jo-1, Centromere and Ribo-P) in the Aptiva CTD Essential reagent is a solid phase immunoassay utilizing fluorescent microparticles. This technology allows each of the ten analytes, along with a human anti-lgG capture antibody (IgG Control Microparticle), to be coated onto eleven uniquely recognizable paramagnetic microparticles, which are combined into one tube. The Aptiva Multi-Analyte 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 ten unique populations of microparticles coated with dsDNA, RNP, Sm, Ro60, Ro52, SS-B, Scl-70, Jo-1, Centromere and Ribo-P, along with the one for the control microparticle, are stored in the reagent cartridge under conditions that preserve the autoantigens 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 Multi-Analyte Instrument, where the microparticles are automatically rehydrated using buffer located within the cartridge. A patient's serum is diluted 1:44.4 fold with Aptiva system rinse by the instrument in a disposable cuvette. A small amount of the diluted sample is combined with assay buffer and the microparticle suspension in a second cuvette, and mixed (final serum dilution: 1:230). This reaction cuvette is incubated for 9 ½ minutes at 37°C. The cuvette is then exposed to a magnet that retains the microparticles in place. The liquid is aspirated, and the microparticles are resuspended as system rinse is added to the cuvette and the magnet is removed. This wash cycle is repeated. During the third wash, no system rinse is added after the aspiration step. After the third wash, phycoerythrin conjugated polyclonal anti-human lgG (known as PE Tracer IgG) is added to the cuvette with microparticles, and mixed. Again, the cuvette is incubated for 9 ½ minutes at 37°C. Three wash steps, as described above, are performed on the microparticles. Following the wash steps, the microparticles are transferred to the optical module of the instrument, where a charge coupled device (CCD) camera takes multiple images to identify and count the twelve unique microparticle regions, as well as determine the amount of conjugate on the microparticles. A twelfth particle, coated with goat anti-human IgG, is present in the reagent as a control to flag low concentrations of IgG in the patient serum sample as an assay verification step. The median fluorescent {7}------------------------------------------------ intensity (MFI) is proportional to the amount of PE Tracer that is bound to the human IgG, which is proportional to the amount of IgG antibodies bound to the corresponding microparticle regions. For quantitation, the ten assays (together as part of the Aptiva CTD Essential Reagent) each utilizes a predefined lot specific Master Curve that is uploaded onto the instrument through the RFID tag on the reagent cartridge. The first time a reagent cartridge of a new lot of Aptiva CTD Essential is placed in the instrument, it must be calibrated. The Aptiva CTD Essential Calibrators are sold separately. The calibration process utilizes the 6 Calibrators that are included in the Calibrators kit to adjust the predefined lot specific dsDNA, RNP, Sm, Ro60, Ro52, SS-B, Scl-70, Jo-1, Centromere and Ribo-P Master Curves into instrument specific Working Curves. These Working Curves are used to calculate FLU (or IU/mL for dsDNA) values from the measured MFI. The Working Curves are lot and instrument specific and stored in the system for use with any reagent cartridge from that lot. The lot specific calibration expires 6 months from the last time the calibration was performed, and re-calibration is required. Aptiva CTD Essential Calibrators and Aptiva CTD Essential Controls are sold separately. The Aptiva CTD Essential Reagent kit contains the following materials: One (1) Aptiva CTD Essential Reagent Cartridge contains the following materials to process 250 determinations: - a. dsDNA, RNP, Sm, Ro60, Ro52, SS-B, Scl-70, Jo-1, Centromere and Ribo-P, and Control paramagnetic particles, preserved. - b. Assay Buffer clear liquid, containing protein stabilizers and preservatives. - c. PE Tracer IgG PE labeled anti-human IgG antibody, containing buffer, protein stabilizers and preservative. - d. Rehydration Buffer containing protein stabilizers and preservatives. ## Intended use(s) The Aptiva CTD Essential Reagent consists of 10 multiplexed immunoassays utilizing particle-based multianalyte technology for the quantitative determination of IgG autoantibodies against dsDNA, and semiquantitative determination of IgG autoantibodies against RNP, Sm, Ro52, Ro60, SS-B, Scl-70, Jo-1, centromere, and Ribo-P in human serum: - The presence of dsDNA antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of systemic lupus erythematosus. - The presence of RNP antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of mixed connective tissue disease and systemic lupus erythematosus. - The presence of Sm antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of systemic lupus erythematosus. - . The presence of Ro52 antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of systemic lupus erythematosus, Sjögren's syndrome, systemic sclerosis, and idiopathic inflammatory myositis. - . The presence of Ro60 antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of systemic lupus erythematosus and Sjögren's syndrome. - . The presence of SS-B antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of systemic lupus erythematosus and Sjögren's syndrome. {8}------------------------------------------------ - . The presence of Scl-70 antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of systemic sclerosis. - The presence of Jo-1 antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of idiopathic inflammatory myositis. - The presence of centromere antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of systemic sclerosis. - The presence of Ribo-P antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of systemic lupus erythematosus. The individual assays included in the Aptiva CTD Essential Reagent are intended for use with the Inova Diagnostics Aptiva System. ## Indications for use Same as intended use. ## Substantial equivalence The Aptiva CTD Essential Reagent has the same intended use and assay principle as the predicate devices. Comparison to predicate device | Similarities | | | |--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Item | Aptiva CTD Essential Reagent
(dsDNA) | QUANTA Flash dsDNA | | Intended Use | The Aptiva CTD Essential Reagent
consists of 10 multiplexed
immunoassays utilizing particle-
based multi-analyte technology
for the quantitative determination
of IgG autoantibodies against
dsDNA, and semi-quantitative
determination of IgG
autoantibodies against RNP, Sm,
Ro52, Ro60, SS-B, Scl-70, Jo-1,
centromere, and Ribo-P in human
serum:

The presence of dsDNA
antibodies, in conjunction with
clinical findings and other
laboratory tests, is an aid in the | QUANTA Flash dsDNA is a
chemiluminescent immunoassay
for the quantitative
determination of IgG anti-double
stranded deoxyribonucleic acid
(dsDNA) antibodies in human
serum. The presence of anti-
dsDNA antibodies, in
conjunction with clinical findings
and other laboratory tests, is an
aid in the diagnosis of Systemic
Lupus Erythematosus. | #### Aptiva CTD Essential Reagent - dsDNA Assay {9}------------------------------------------------ | Similarities | | | |----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------| | Item | Aptiva CTD Essential Reagent (dsDNA) | QUANTA Flash dsDNA | | | diagnosis of systemic lupus
erythematosus.

The Aptiva CTD Essential Reagent
is intended for use with the Inova
Diagnostics Aptiva System. | | | Assay Methodology | solid phase immunoassay | solid phase immunoassay | | Antigen | Synthetic DNA | Synthetic DNA | | Sample Type | human serum | human serum | | Solid Phase | paramagnetic microparticles | paramagnetic microparticles | | Units | International Units (IU/mL) | International Units (IU/mL) | | Cut-off | 27.00 IU/mL - 35.00 IU/mL | 27.00 IU/mL - 35.00 IU/mL | | Differences | | | | Item | Aptiva CTD Essential Reagent (dsDNA) | QUANTA Flash dsDNA | | Detection/Operating
Principle | fluorescent immunoassay | chemiluminescent immunoassay | | Conjugate | phycoerythrin conjugated
polyclonal anti-human IgG
antibody | Isoluminol conjugated
monoclonal anti-human IgG
antibody | | Analytical Measuring
Range | 2.30 IU/mL – 814.10 IU/mL | 9.8 IU/mL - 666.9 IU/mL | | Calibration | Lot specific Master Curve + 6
calibrators (sold separately) | Lot specific Master Curve + 2
calibrators (sold separately) | # Aptiva CTD Essential Reagent – RNP Assay | Similarities | | | |-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Item | Aptiva CTD Essential Reagent (RNP) | QUANTA Flash RNP | | Intended Use | The Aptiva CTD Essential Reagent consists of 10 multiplexed immunoassays utilizing particle-based multi-analyte technology for the quantitative determination of IgG autoantibodies against dsDNA, and semi-quantitative determination of IgG | The QUANTA Flash RNP is a chemiluminescent immunoassay for the semi-quantitative determination of IgG anti-ribonucleoprotein (RNP) antibodies in human serum. The presence of anti-RNP antibodies, in conjunction with clinical | | Similarities | | | | Item | Aptiva CTD Essential Reagent (RNP) | QUANTA Flash RNP | | | autoantibodies against RNP, Sm, Ro52, Ro60, SS-B, Scl-70, Jo-1, centromere, and Ribo-P in human serum:

The presence of RNP antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of mixed connective tissue disease and systemic lupus erythematosus.

The individual assays included in the Aptiva CTD Essential Reagent are intended for use with the Inova Diagnostics Aptiva System. | findings and other laboratory tests, can aid in the diagnosis of Systemic Lupus Erythematosus (SLE) and Mixed Connective Tissue Disease (MCTD). | | Assay Methodology | solid phase immunoassay | solid phase immunoassay | | Antigen | Native RNP | Native RNP | | Sample Type | human serum | human serum | | Solid Phase | paramagnetic microparticles | paramagnetic microparticles | | Differences | | | | Item | Aptiva CTD Essential Reagent (RNP) | QUANTA Flash RNP | | Detection/Operating Principle | fluorescent immunoassay | chemiluminescent immunoassay | | Conjugate | phycoerythrin conjugated polyclonal anti-human IgG antibody | Isoluminol conjugated monoclonal anti-human IgG antibody | | Units | fluorescent light units (FLU) | chemiluminescent units (CU) | | Cut-off | 5.00 FLU | 20.0 CU | | Analytical Measuring Range | 0.50 FLU – 181.99 FLU | 3.5 CU – 643.8 CU | | Calibration | Lot specific Master Curve + 6 calibrators (sold separately) | Lot specific Master Curve + 2 calibrators (sold separately) | {10}------------------------------------------------ {11}------------------------------------------------ | Similarities | | | |-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Item | Aptiva CTD Essential Reagent (Sm) | Orgentec anti-Sm | | Intended Use | The Aptiva CTD Essential Reagent consists of 10 multiplexed immunoassays utilizing particle-based multi-analyte technology for the quantitative determination of IgG autoantibodies against dsDNA, and semi-quantitative determination of IgG autoantibodies against RNP, Sm, Ro52, Ro60, SS-B, Scl-70, Jo-1, centromere, and Ribo-P in human serum:

The presence of Sm antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of systemic lupus erythematosus.

The Aptiva CTD Essential Reagent is intended for use with the Inova Diagnostics Aptiva System. | Anti-Sm is an ELISA test system for the quantitative measurement of IgG class autoantibodies against Sm in human serum or plasma. This product is intended for professional in vitro diagnostic use only.

The detection of autoantibodies against Sm proteins is a component of the multi-parametric ACR criteria for the diagnosis of systemic lupus erythematosus (SLE). The detection of Sm antibodies serves as a prognostic marker for SLE, there is a relationship between the appearance of Sm antibodies and severe organ manifestations of the disease. Evaluation of a test result should always take into account all clinical and laboratory diagnostic findings. | | Assay Methodology | solid phase immunoassay | solid phase immunoassay | # Aptiva CTD Essential Reagent – Sm Assay {12}------------------------------------------------ | Differences | | | |-------------------------------|-------------------------------------------------------------|--------------------------------------------------| | Item | Aptiva CTD Essential Reagent (Sm) | Orgentec anti-Sm | | Detection/Operating Principle | fluorescent immunoassay | Chromogenic immunoassay | | Conjugate | phycoerythrin conjugated polyclonal anti-human IgG antibody | HRP conjugated anti-human IgG antibody | | Antigen | Synthetic Sm peptide | Synthetic Sm peptide | | Sample Type | human serum | human serum or plasma | | Solid Phase | paramagnetic microparticles | ELISA | | Units | fluorescent light units (FLU) | Units (U/mL) | | Cut-off | 5.00 FLU | 25 U/mL | | Analytical Measuring Range | 0.25 FLU – 256.00 FLU | 1 U/mL – 200.0 U/mL | | Calibration | Lot specific Master Curve + 6 calibrators (sold separately) | Calibration Curve using 6 calibrators (included) | # Aptiva CTD Essential Reagent – Ro52 Assay | Similarities | | | |--------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Item | Aptiva CTD Essential Reagent (Ro52) | QUANTA Flash Ro52 | | Intended Use | The Aptiva CTD Essential Reagent consists of 10 multiplexed immunoassays utilizing particle-based multi-analyte technology for the quantitative determination of IgG autoantibodies against dsDNA, and semi-quantitative determination of IgG autoantibodies against RNP, Sm, Ro52, Ro60, SS-B, Scl-70, Jo-1, centromere, and Ribo-P in human serum:

The presence of Ro52 antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of systemic lupus erythematosus, | QUANTA Flash Ro52 is a chemiluminescent immunoassay for the semi-quantitative determination of IgG anti-Ro52 autoantibodies in human serum. The presence of anti-Ro52 autoantibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of Systemic Lupus Erythematosus, Sjögren's Syndrome, Systemic Sclerosis, Idiopathic Inflammatory Myopathies. | {13}------------------------------------------------ | Similarities | | | |----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------| | Item | Aptiva CTD Essential Reagent (Ro52) | QUANTA Flash Ro52 | | | Sjögren's syndrome, systemic
sclerosis, and idiopathic
inflammatory myositis.

The Aptiva CTD Essential Reagent
is intended for use with the Inova
Diagnostics Aptiva System. | | | Assay Methodology | solid phase immunoassay | solid phase immunoassay | | Antigen | Recombinant Ro52 | Recombinant Ro52 | | Sample Type | human serum | human serum | | Solid Phase | paramagnetic microparticles | paramagnetic microparticles | | Differences | | | | Item | Aptiva CTD Essential Reagent (Ro52) | QUANTA Flash Ro52 | | Detection/Operating
Principle | fluorescent immunoassay | chemiluminescent immunoassay | | Conjugate | phycoerythrin conjugated
polyclonal anti-human IgG
antibody | Isoluminol conjugated
monoclonal anti-human IgG
antibody | | Units | fluorescent light units (FLU) | chemiluminescent units (CU) | | Cut-off | 5.00 FLU | 20.0 CU | | Analytical Measuring
Range | 0.25 FLU – 196.27 FLU | 2.3 CU – 1685.3 CU | | Calibration | Lot specific Master Curve + 6
calibrators (sold separately) | Lot specific Master Curve + 2
calibrators (sold separately) | {14}------------------------------------------------ | Similarities | | | |-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Item | Aptiva CTD Essential Reagent (Ro60) | QUANTA Flash Ro60 | | Intended Use | The Aptiva CTD Essential Reagent consists of 10 multiplexed immunoassays utilizing particle-based multi-analyte technology for the quantitative determination of IgG autoantibodies against dsDNA, and semi-quantitative determination of IgG autoantibodies against RNP, Sm, Ro52, Ro60, SS-B, Scl-70, Jo-1, centromere, and Ribo-P in human serum:

The presence of Ro60 antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of systemic lupus erythematosus and Sjögren's syndrome.

The Aptiva CTD Essential Reagent is intended for use with the Inova Diagnostics Aptiva System. | QUANTA Flash Ro60 is a chemiluminescent immunoassay for the semi-quantitative determination of IgG anti-Ro60 autoantibodies in human serum. The presence of anti-Ro60 autoantibodies, in conjunction with clinical findings and other laboratory tests, aids in the diagnosis of Systemic Lupus Erythematosus and Sjögren's Syndrome. | | Assay Methodology | solid phase immunoassay | solid phase immunoassay | | Antigen | Recombinant Ro60 | Recombinant Ro60 | | Sample Type | human serum | human serum | | Solid Phase | paramagnetic microparticles | paramagnetic microparticles | Aptiva CTD Essential Reagent – Ro60 Assay | Differences | | | |-------------|----------------------------------------|-------------------| | Item | Aptiva CTD Essential Reagent
(Ro60) | QUANTA Flash Ro60 | | | Detection/Operating
Principle | | {15}------------------------------------------------ | | phycoerythrin conjugated
polyclonal anti-human IgG
antibody | Isoluminol conjugated
monoclonal anti-human IgG
antibody | |-------------------------------|-------------------------------------------------------------------|----------------------------------------------------------------| | Conjugate | | | | Units | fluorescent light units (FLU) | chemiluminescent units (CU) | | Cut-off | 5.00 FLU | 20.0 CU | | Analytical Measuring
Range | 0.50 FLU – 583.72 FLU | 4.9 CU – 1374.8 CU | | Calibration | Lot specific Master Curve + 6
calibrators (sold separately) | Lot specific Master Curve + 2
calibrators (sold separately) | # Aptiva CTD Essential Reagent – SS-B Assay | Similarities | | | |-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Item | Aptiva CTD Essential Reagent (SS-B) | QUANTA Flash SS-B | | Intended Use | The Aptiva CTD Essential Reagent consists of 10 multiplexed immunoassays utilizing particle-based multi-analyte technology for the quantitative determination of IgG autoantibodies against dsDNA, and semi-quantitative determination of IgG autoantibodies against RNP, Sm, Ro52, Ro60, SS-B, Scl-70, Jo-1, centromere, and Ribo-P in human serum:

The presence of SS-B antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of systemic lupus erythematosus and Sjögren's syndrome.

The Aptiva CTD Essential Reagent is intended for use with the Inova Diagnostics Aptiva System. | QUANTA Flash SS-B is a chemiluminescent immunoassay for the semi-quantitative determination of IgG anti-SS-B autoantibodies in human serum. The presence of anti-SS-B autoantibodies, in conjunction with clinical findings and other laboratory tests is an aid in the diagnosis of Sjögren's Syndrome and Systemic Lupus Erythematosus. | | Assay Methodology | solid phase immunoassay | solid phase immunoassay | | Antigen | Recombinant SS-B | Recombinant SS-B | | Sample Type | human serum | human serum | {16}------------------------------------------------ | Similarities | | | |--------------|-----------------------------------------|-----------------------------| | Item | Aptiva CTD Essential Reagent (SS-
B) | QUANTA Flash SS-B | | Solid Phase | paramagnetic microparticles | paramagnetic microparticles | | Differences | | | |-------------------------------|-------------------------------------------------------------------|----------------------------------------------------------------| | Item | Aptiva CTD Essential Reagent (SS-B) | QUANTA Flash SS-B | | Detection/Operating Principle | fluorescent immunoassay | chemiluminescent immunoassay | | Conjugate | phycoerythrin conjugated
polyclonal anti-human IgG
antibody | Isoluminol conjugated
monoclonal anti-human IgG
antibody | | Units | fluorescent light units (FLU) | chemiluminescent units (CU) | | Cut-off | 5.00 FLU | 20.0 CU | | Analytical Measuring Range | 0.40 FLU – 195.84 FLU | 3.3 CU – 1550.0 CU | | Calibration | Lot specific Master Curve + 6
calibrators (sold separately) | Lot specific Master Curve + 2
calibrators (sold separately) | # Aptiva CTD Essential Reagent – Scl-70 Assay | Similarities |… --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LLL/K213403](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LLL/K213403) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com