(260 days)
Not Found
No
The description details a standard automated immunoassay system that uses a predefined master curve and calibrators to calculate results. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
This device is a diagnostic tool used to detect antibodies for the diagnosis of idiopathic inflammatory myopathy, not to treat a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that "The presence of antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of idiopathic inflammatory myopathy." This directly indicates its role in disease diagnosis.
No
The device is an immunoassay kit that runs on a specific automated instrument (BIO-FLASH®). While the instrument includes software, the device itself is a collection of reagents and calibrators, not solely software.
Based on the provided information, the QUANTA Flash Jo-1 device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "semi-quantitative determination of IgG anti-Jo-1 antibodies in human serum." This is a test performed in vitro (outside the body) on a biological sample (human serum) to provide information for diagnosis.
- Indications for Use: It states the presence of these antibodies is "an aid in the diagnosis of idiopathic inflammatory myopathy." This directly links the test results to a diagnostic purpose.
- Device Description: The description details a laboratory assay that analyzes human serum samples using reagents and an automated instrument. This is characteristic of an in vitro diagnostic test.
- Components: The kit contains reagents, calibrators, and controls, which are standard components of IVD assays used for accurate and reliable testing of biological samples.
- Performance Studies: The document describes both analytical and clinical performance studies, which are required for IVD devices to demonstrate their accuracy and clinical utility.
- Predicate Device: The mention of a predicate device (K053653; FIDIS Connective 10) further indicates that this device is being compared to another legally marketed IVD device.
All these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
QUANTA Flash Jo-1 is a chemiluminescent immunoassay for the semi-quantitative determination of IgG anti-Jo-1 antibodies in human serum. The presence of antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of idiopathic inflammatory myopathy.
QUANTA Flash Jo-1 Calibrators are intended for use with the QUANTA Flash Jo-1 Reagents for the determination of Ig G anti-Jo-1 antibodies in human serum. Each calibrator establishes a point of reference for the working curve that is used to calculate unit values.
QUANTA Flash Jo-1 Controls are intended for use with the QUANTA Flash Jo-1 Reagents for quality control in the determination of IgG anti-Jo-1 antibodies in human serum.
Product codes (comma separated list FDA assigned to the subject device)
LLL, JIT, JJX
Device Description
The QUANTA Flash Jo-1 assay is designed to run on the BIO-FLASH® instrument. This platform is a fully automated closed system with continuous load and random access capabilities that automatically processes the samples, runs the assay and reports the results. It includes liquid handling hardware, luminometer and computer with software-user interface. The QUANTA Flash Jo-1 assay utilizes a reagent cartridge format, which is compatible with the BIO-FLASH instrument.
Recombinant Jo-1 antigen is coated onto paramagnetic beads, which is stored in the reagent cartridge as a suspension. When the cartridge is ready to be used for the first time, the entire cartridge is inverted several times to thoroughly mix the reagent cartridge is then loaded onto the BIO-FLASH instrument. Samples are also loaded onto the instrument in sample racks. Serum samples are diluted by the BIO-FLASH with system rinse in a small disposable plastic cuvette. Small amounts of the diluted patient serum, the beads, and assay buffer are combined into a second cuvette, and mixed. This cuvette is then incubated at 37°C. The beads are magnetized and washed several times. Isoluminol conjugated anti-human IgG antibodies are then added to the cuvette, and again incubated at 37°C. The beads are magnetized and washed repeatedly. The isoluminol conjugate is oxidized when Trigger 1 (Fe(II)coproporphyrin in sodium hydroxide solution) and Trigger 2 (urea-hydrogen peroxide in sodium chloride solution) are added to the cuvette, and the flash of light produced from this reaction is measured as Relative Light Units (RLU) by the BIO-FLASH optical system. The RLU are proportional to the amount of isoluminol conjugate that is bound to the human IgG, which is in turn proportional to the amount of anti-Jo-1 antibodies bound to the corresponding beads.
For quantitation, the QUANTA Flash Jo-1 assay utilizes a predefined lot specific Master Curve that is uploaded onto the instrument through the reagent cartridge barcode. Every new lot number of reagent cartridge must be calibrated before first use, with the QUANTA Flash Jo-1 Calibrators. Based on the results obtained with the two Calibrators included in the Calibrator Set (sold separately), an instrument specific Working Curve is created, which is used to calculate chemiluminescent units (CU) from the instrument signal (RLU) obtained for each sample.
The QUANTA Flash Jo-1 kit contains the following materials:
One (1) QUANTA Flash Jo-1 Reagent Cartridge
The QUANTA Flash Jo-1 reagent cartridge contains the following reagents for 50 determinations:
- a. Jo-1 coated paramagnetic beads, in a suspension containing buffer, protein stabilizers and preservative.
- b. Assay buffer - colored pink, containing buffer, Tween 20, protein stabilizers and preservatives.
- C. Tracer IgG - Isoluminol labeled anti-human IgG antibodies in buffer, containing protein stabilizers and preservative.
The QUANTA Flash Jo-1 Calibrators kit contains two vials of Calibrator 1 and two vials of Calibrator 2:
QUANTA Flash Jo-1 Calibrators:
- І QUANTA Flash Jo-1 Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to Jo-1 in buffer, stabilizer and preservative.
- QUANTA Flash Jo-1 Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL
prediluted, ready to use reagent. Calibrators contain human antibodies to Jo-1 in buffer, stabilizer and preservative.
The QUANTA Flash Jo-1 Controls kit contains two vials of Negative Control and two vials of Positive Control:
QUANTA Flash Jo-1 Controls:
- -QUANTA Flash Jo-1 Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to Jo-1 in buffer, stabilizer and preservative.
- QUANTA Flash Jo-1 Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to Jo-1 in buffer, stabilizer and preservative.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision: The precision of the QUANTA Flash Jo-1 assay was evaluated on 9 samples containing various concentrations of Jo-1 antibodies in accordance with CLSI EP05-A2. Samples were run in duplicates, twice a day, for 20 days. Data analyzed with Analyse-it for Excel method evaluation software.
Acceptance criteria: Total %CV:
§ 866.5100 Antinuclear antibody immunological test system.
(a)
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).(b)
Classification. Class II (performance standards).
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 12, 2016
INOVA Diagnostics, Inc. Dr. Gabriella Lakos Director, Research and Development 9900 Old Grove Road San Diego, CA 92131
Re: K151429
Trade/Device Name: Quanta Flash® Jo-1 Quanta Flash® Jo-1 Calibrators Quanta Flash® Jo-1 Controls Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear Antibodies Immunological Test System Regulatory Class: II Product Code: LLL, JIT, JJX Dated: January 14, 2016 Received: January 15, 2016
Dear Dr. Lakos:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements
1
as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kelly Oliner -S
FOR
Leonthena R. Carrington, MS, MBA, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151429
Device Name
QUANTA Flash® Jo-1, QUANTA Flash® Jo-1 Calibrators, QUANTA Flash® Jo-1 Controls
Indications for Use (Describe)
QUANTA Flash Jo-1 is a chemiluminescent immunoassay for the semi-quantitative determination of IgG anti-Jo-1 antibodies in human serum. The presence of antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of idiopathic inflammatory myopathy.
QUANTA Flash Jo-1 Calibrators are intended for use with the QUANTA Flash Jo-1 Reagents for the determination of Ig G anti-Jo-1 antibodies in human serum. Each calibrator establishes a point of reference for the working curve that is used to calculate unit values.
QUANTA Flash Jo-1 Controls are intended for use with the OUANTA Flash Jo-1 Reagents for quality control in the determination of IgG anti-Jo-1 antibodies in human serum.
| 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)
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3
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510(k) Summary
QUANTA Flash® Jo-1 QUANTA Flash® Jo-1 Calibrators QUANTA Flash® Jo-1 Controls
Table of Contents
| Administrative data |
|---|
| Predicate device |
| Device description |
| Intended use(s) |
| Indications for use…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… |
| Substantial equivalence |
| Comparison to predicate device |
| Analytical performance characteristics |
| Quantitation and units of measure |
| Value assignment and traceability of Calibrators and Controls |
| Precision |
| Reproducibility |
| Limit of Blank (LoB) and Limit of Detection (LoD) |
| Analytical Measuring Range (AMR) |
| Auto-rerun function and reportable results |
| High concentration hook effect |
| Linearity |
| Interference |
| Cross-reactivity |
| Lot to lot comparison |
| Sample Stability |
| Reagent Stability |
| Cut-off, reference range |
| Clinical performance characteristics |
| Clinical sensitivity, specificity |
4
510(k) Summary QUANTA Flash® Jo-1
Comparison with predicate device ............................................................................................................................................
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(s) | |
| Devices in the submission: | QUANTA Flash® Jo-1
QUANTA Flash® Jo-1 Calibrators
QUANTA Flash® Jo-1 Controls | |
| Scientific contact: | Gabriella Lakos, Director of Research, Rheumatology
Inova Diagnostics, Inc.
9900 Old Grove Road, San Diego, CA, 92131
Phone: 858-586-9900/1393
Fax: 858-863-0025
email: glakos@inovadx.com | |
| Quality Systems contact: | Ronda Elliott, VP, Quality Systems and RA
Inova Diagnostics, Inc
9900 Old Grove Road, San Diego, CA, 92131
Phone: 858-586-9900/1381
Fax: 858-863-0025
email: relliot@inovadx.com | |
| Device name (assay kit): | Proprietary name: | QUANTA Flash® Jo-1 |
| | Common name: | Anti-Jo-1 Chemiluminescent Immunoassay |
| | Classification name: | anti- Jo-1 antibodies, antigen and control |
| Regulation Description | Extractable Antinuclear Antibody, Antigen and Control | |
| Regulation Medical Specialty | Immunology | |
| Review Panel | Immunology | |
| Product Code | LLL | |
5
| Regulation Number | 866.5100 |
|---|---|
| Device Class | 2 |
| Device name (Calibrators): | Proprietary name: QUANTA Flash® Jo-1 Calibrators |
| Common name: Jo-1 Calibrators | |
| Classification name: Calibrator, secondary | |
| Regulation Description | Calibrator |
| Regulation Medical Specialty | Clinical Chemistry |
| Product Code | JIT |
| Regulation Number | 862.1150 |
| Device Class | 2 |
| Device name (Controls): | Proprietary name: QUANTA Flash® Jo-1 Controls |
| Common name: Jo-1 Controls | |
| Classification name: single (specified) analyte controls (assayed and unassayed) | |
| Regulation Description | Quality control material (assayed and unassayed) |
| Regulation Medical Specialty | Clinical Chemistry |
| Product Code | JJX |
| Regulation Number | 862.1660 |
| Device Class | 1 (reserved) |
Predicate device
FIDIS Connective 10, 510(k) number: K053653
Device description
The QUANTA Flash Jo-1 assay is designed to run on the BIO-FLASH® instrument. This platform is a fully automated closed system with continuous load and random access capabilities that automatically processes the samples, runs the assay and reports the results. It includes liquid handling hardware, luminometer and computer with software-user interface. The QUANTA Flash Jo-1 assay utilizes a reagent cartridge format, which is compatible with the BIO-FLASH instrument.
Recombinant Jo-1 antigen is coated onto paramagnetic beads, which is stored in the reagent cartridge
6
as a suspension. When the cartridge is ready to be used for the first time, the entire cartridge is inverted several times to thoroughly mix the reagent cartridge is then loaded onto the BIO-FLASH instrument. Samples are also loaded onto the instrument in sample racks. Serum samples are diluted by the BIO-FLASH with system rinse in a small disposable plastic cuvette. Small amounts of the diluted patient serum, the beads, and assay buffer are combined into a second cuvette, and mixed. This cuvette is then incubated at 37°C. The beads are magnetized and washed several times. Isoluminol conjugated anti-human IgG antibodies are then added to the cuvette, and again incubated at 37°C. The beads are magnetized and washed repeatedly. The isoluminol conjugate is oxidized when Trigger 1 (Fe(II)coproporphyrin in sodium hydroxide solution) and Trigger 2 (urea-hydrogen peroxide in sodium chloride solution) are added to the cuvette, and the flash of light produced from this reaction is measured as Relative Light Units (RLU) by the BIO-FLASH optical system. The RLU are proportional to the amount of isoluminol conjugate that is bound to the human IgG, which is in turn proportional to the amount of anti-Jo-1 antibodies bound to the corresponding beads.
For quantitation, the QUANTA Flash Jo-1 assay utilizes a predefined lot specific Master Curve that is uploaded onto the instrument through the reagent cartridge barcode. Every new lot number of reagent cartridge must be calibrated before first use, with the QUANTA Flash Jo-1 Calibrators. Based on the results obtained with the two Calibrators included in the Calibrator Set (sold separately), an instrument specific Working Curve is created, which is used to calculate chemiluminescent units (CU) from the instrument signal (RLU) obtained for each sample.
The QUANTA Flash Jo-1 kit contains the following materials:
One (1) QUANTA Flash Jo-1 Reagent Cartridge
The QUANTA Flash Jo-1 reagent cartridge contains the following reagents for 50 determinations:
- a. Jo-1 coated paramagnetic beads, in a suspension containing buffer, protein stabilizers and preservative.
- b. Assay buffer - colored pink, containing buffer, Tween 20, protein stabilizers and preservatives.
- C. Tracer IgG - Isoluminol labeled anti-human IgG antibodies in buffer, containing protein stabilizers and preservative.
The QUANTA Flash Jo-1 Calibrators kit contains two vials of Calibrator 1 and two vials of Calibrator 2:
QUANTA Flash Jo-1 Calibrators:
- ၊ QUANTA Flash Jo-1 Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to Jo-1 in buffer, stabilizer and preservative.
- QUANTA Flash Jo-1 Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL
7
prediluted, ready to use reagent. Calibrators contain human antibodies to Jo-1 in buffer, stabilizer and preservative.
The QUANTA Flash Jo-1 Controls kit contains two vials of Negative Control and two vials of Positive Control:
QUANTA Flash Jo-1 Controls:
- -QUANTA Flash Jo-1 Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to Jo-1 in buffer, stabilizer and preservative.
- QUANTA Flash Jo-1 Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to Jo-1 in buffer, stabilizer and preservative.
Intended use(s)
QUANTA Flash Jo-1 is a chemiluminescent immunoassay for the semi-quantitative determination of IgG anti-Jo-1 antibodies in human serum. The presence of antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of idiopathic inflammatory myopathies.
QUANTA Flash Jo-1 Calibrators are intended for use with the QUANTA Flash Jo-1 Reagents for the determination of IgG anti-Jo-1 antibodies in human serum. Each calibrator establishes a point of reference for the working curve that is used to calculate unit values.
QUANTA Flash Jo-1 Controls are intended for use with the QUANTA Flash Jo-1 Reagents for quality control in the determination of IgG anti-Jo-1 antibodies in human serum.
Indications for use
Same as Intended use.
Substantial equivalence
The QUANTA Flash Jo-1 Reagent, the QUANTA Flash Jo-1 Calibrators and the QUANTA Flash Jo-1 Controls have the same intended use and assay principle as the predicate device, FIDIS Connective 10. Comparison to predicate device
QUANTA Flash Jo-1 reagent kit
Similarities
8
| Item | QUANTA Flash Jo-1 | Predicate Device |
|---|---|---|
| Intended use | Semi-quantitative determination of | |
| anti-Jo-1 antibodies in human serum | Semi-quantitative detection of anti-Jo-1 | |
| antibodies in human serum | ||
| Assay methodology | Solid phase immunoassay | Solid phase immunoassay |
| Antigen | Recombinant antigen | Recombinant antigen |
| Shelf life | One year | One year |
| Sample Type | Serum | Serum |
| Differences | ||
|---|---|---|
| Item | QUANTA Flash Jo-1 | Predicate Device |
| Detection/ | ||
| Operating principle | Chemiluminescent immunoassay | Multiplex bead-based flow cytometric |
| fluorescent immunoassay | ||
| Solid phase | Paramagnetic microparticles (beads) | Color-coded microspheres |
| Conjugate | Isoluminol conjugated anti-human | |
| IgG | Phycoerythrin conjugated anti-human | |
| IgG | ||
| Calibration | Lot specific Master Curve + two | |
| calibrators (sold separately) | Calibration system interpolates | |
| fluorescent intensity | ||
| (Included in the kit) |
QUANTA Flash Jo-1 Calibrators
| Item | QUANTA Flash Jo-1 Calibrators | Predicate Device |
|---|---|---|
| Intended use | For use with the QUANTA Flash Jo-1 Reagents Each calibrator establishes a point of reference for the working curve that is used to calculate unit values. | No separate intended use; calibrators are part of the kit. |
| Analyte | Anti-Jo-1 antibodies | Anti-Jo-1 antibodies |
| Method | QUANTA Flash Jo-1 chemiluminescent immunoassay | Included in FIDIS Connective 10 |
| Matrix | Human serum, stabilizer, and preservative | Diluted human serum |
| Unit | CU (Chemiluminescent units) (arbitrary) | AU/mL (arbitrary) |
| Physico-chemical characteristics | Liquid, prediluted, ready to use | Liquid, prediluted, ready to use |
| Storage | 2-8 °C | 2-8 °C |
| Shelf life | One year | One year |
QUANTA Flash Jo-1 Controls
9
| Item | QUANTA Flash Jo-1 Controls | Predicate Device |
|---|---|---|
| Intended use | For use with the QUANTA Flash Jo-1 reagents for quality control in the determination of IgG anti-Jo-1 autoantibodies in human serum. | No separate intended use; controls are part of the kit. |
| Analyte | Anti-Jo-1 antibodies | Anti-Jo-1 antibodies |
| Method | QUANTA Flash Jo-1 chemiluminescent immunoassay | Included in FIDIS Connective 10 |
| Matrix | Human serum, stabilizers, and preservative | Diluted human serum |
| Unit | CU (Chemiluminescent units) (arbitrary) | AU/mL (arbitrary) |
| Physico-chemical characteristics | Liquid, ready to use | Liquid, to be diluted |
| Levels | 2 (negative and positive) | 2 (negative and positive) |
| Storage | 2-8 °C | 2-8 °C |
| Shelf life | One year | One year |
Analytical performance characteristics
Quantitation and units of measure
For quantitation, the QUANTA Flash Jo-1 assay utilizes a lot specific Master Curve that is uploaded onto the instrument through the reagent cartridge barcode. The Master Curve for QUANTA Flash Jo-1 consists of 6 Standards. These Master Curve Standards are used to create the lot specific Master Curve during the manufacturing procedure.
List of Jo-1 Standards:
| Material | Assigned Value |
|---|---|
| Jo-1 Master Curve Standard 1 | 2.2 CU |
| Jo-1 Master Curve Standard 2 | 19.0 CU |
| Jo-1 Master Curve Standard 3 | 38.9 CU |
| Jo-1 Master Curve Standard 4 | 71.1 CU |
| Jo-1 Master Curve Standard 5 | 320.2 CU |
| Jo-1 Master Curve Standard 6 | 1147.2 CU |
Value assignment and traceability of Calibrators and Controls
The QUANTA Flash Jo-1 Calibrators and Controls are manufactured by diluting human serum that contains high titer of anti-Jo-1 antibodies with stabilizer and preservative. The human serum is obtained from commercial sources and it is tested for markers of infectious substances.
10
510(k) Summary QUANTA Flash® Jo-1
The target CU is achieved through trial dilutions on small scale. Once a dilution is selected, the Calibrators and Control are bulked, tested, and adjusted. Upon completion of the manufacturing process, the Calibrators and Controls are tested on at least two instruments, on at least two lots of reagent cartridge, in replicates of 10 to determine final value assignment.
Calibrator and Control values are directly traceable to the in-house Standards that are used to create the Master Curves for the QUANTA Flash Jo-1 assay.
| Material | Manufacturing
Target Value | Manufacturing
Target Range |
|-----------------------|-------------------------------|-------------------------------|
| Jo-1 Calibrator 1 | 19 CU | 17–21 CU |
| Jo-1 Calibrator 2 | 320 CU | 280–360 CU |
| Jo-1 Negative Control | 10 CU | 8–12 CU |
| Jo-1 Positive Control | 50 CU | 40–60 CU |
Jo-1 Calibrators and Controls with target manufacturing values:
Precision
The precision of the QUANTA Flash Jo-1 assay was evaluated on 9 samples containing various concentrations of Jo-1 antibodies in accordance with CLSI EP05-A2, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline. Samples were run in duplicates, twice a day, for 20 days.
Data were analyzed with the Analyse-it for Excel method evaluation software, and within run, between run, between day and total precision were calculated.
Acceptance criteria: Total %CV: 1147.2 CU after further diluting it by 20 fold, thereby bringing the measured value within the AMR. The final result will be calculated by the software by taking into account the additional dilution factor. As the highest value that can be directly measured is 1147.2 CU, the highest value that can be reported is 22944 CU.
High concentration hook effect
To assess hook effect, measurement signal (relative light units, RLU) was examined by performing serial dilutions of two high positive samples (with results above the AMR when tested as neat samples). RLU values showed increase with increasing antibody concentrations above the AMR, thereby confirming that high positive specimens above the analytical measuring range do not show hook effect up to 65625.5 CU in the Jo-1 assay (the highest concentration that was tested).
Linearity
The linearity of the AMR was evaluated by a study according to CLSI EP6-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approved Guideline. Fiver serum samples with various Jo-1 antibody concentrations were diluted with negative serum in 10% increments (from 0% to 90% negative serum) to obtain values that cover the AMR. The dilutions were assayed in duplicates. Percent recovery of obtained mean results was calculated compared to the expected mean results (based on the dilution factor). Moreover, obtained values of individual replicates were plotted against expected values, and linear regression analysis was performed.
Acceptance criteria:
-
Recovery is between 80-120%, or ± 4 CU, whichever is greater.
-
For linear regression analysis, slope is between 0.9-1.1, and R-is ≥ 0.95.
13
| Sample | Test Range (CU) | Slope (95% CI) | R2 |
|---|---|---|---|
| Sample 1 | 3.0 - 14.4 | 0.99 (0.96 to 1.02) | 1.00 |
| Sample 2 | 4.9 - 44.3 | 0.99 (0.95 to 1.02) | 0.99 |
| Sample 3 | 10.1 - 110.5 | 0.99 (0.98 to 1.01) | 0.99 |
| Sample 4 | 60.1 - 686.8 | 1.00 (0.95 to 1.04) | 0.99 |
| Sample 5 | 139.3 - 1126.4 | 0.92 (0.89 to 0.96) | 1.00 |
All five specimens showed dilution linearity individually.
The combined data yielded the following results with linear regression:
| Sample | Test Range (CU) | Slope (95% CI) | R2 |
|---|---|---|---|
| All | 3.0 - 1126.4 | 0.96 (0.95 to 0.97) | 1.00 |
These data demonstrate the linearity of the analytical measuring range (2.2 CU – 1147.2 CU) of the QUANTA Flash Jo-1 assay.
Interference
The interference study was performed according to CLSI EPO7-A2, Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition. Three specimens were tested (negative: 11.3 CU; around cutoff: 21.1 CU; positive: 117.0 CU). Interfering substances (hemoglobin, bilirubin, and triglycerides/cholesterol) were spiked into every specimen at three different concentrations in 10% of total specimen volume, and the resulting samples were assessed in triplicates with the QUANTA Flash Jo-1 assay. Moreover, 3 additional samples (negative: 7.3 CU; low positive: 32.5 CU; high positive: 123 CU) were tested for RF interference by combining them with different proportions of a high positive RF IgM serum sample (1894 IU/mL). Recovery of the unit values was calculated compared to control samples spiked with the same volume of diluents (10% of total sample volume, except for RF). For the RF interference study, recovery values were calculated compared to control samples created by adding negative serum to the test serum in the same proportions as the RF serum was used). Acceptance criteria for the interference studies were 85% - 115% recovery for samples above the cutoff, and ± 4 CU difference for samples below the cutoff.
No interference was detected with bilirubin up to 10 mg/dL (recovery: 89% to 98%), hemoglobin up to 200 mg/dL (recovery: 86% to 101% or