(378 days)
Not Found
No
The document describes automated data analysis and algorithms but does not mention AI, ML, or deep learning. The performance studies are based on traditional metrics and comparisons to predicate devices, not on training or test sets typically associated with AI/ML models.
No.
The device is an in vitro diagnostic test system used to aid in the diagnosis of Rheumatoid Arthritis by detecting specific antibodies; it does not directly treat or prevent a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an in vitro diagnostic test system" and is "intended for use in clinical laboratories as an aid in the diagnosis of Rheumatoid Arthritis".
No
The device description explicitly states that the device consists of both an assay kit and a "Platform" which is described as a "multiplex immunoassay instrument" that includes automated pipetting, a fluorescent scanner, washing and drying stations, and other ancillary hardware components. While it includes software, it is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is an "in vitro diagnostic test system" for the detection of specific antibodies in human serum specimens. It also states it is intended for use in clinical laboratories as an aid in the diagnosis of Rheumatoid Arthritis.
- Device Description: The description details a system that analyzes biological samples (human serum) to provide diagnostic information.
- Clinical Context: The device is intended for use in clinical laboratories and the results are used in conjunction with other findings for diagnosis.
These points clearly align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IgX PLEX™ Rheumatoid Arthritis Qualitative Assay and SQiDworks™ Diagnostics Platform is an in vitro diagnostic test system for the qualitative detection of the IgA and IgM classes of Rheumatoid Factors and the IgG class of anti-cyclic citrullinated peptide antibodies (CCP-proprietary third generation equivalent formulation) in human serum specimens.
The IgX PLEX™ Rheumatoid Arthritis Qualitative Assay is intended for use in clinical laboratories as an aid in the diagnosis of Rheumatoid Arthritis in conjunction with other laboratory and clinical findings, and requires the SQiDworks™ Diagnostics Platform.
Product codes (comma separated list FDA assigned to the subject device)
DHR, NHX, NHX, NSU
Device Description
The device consists of the IgX PLEX™ Rheumatoid Arthritis Qualitative Assay (RL1 kit) and the SQiDworks™ Diagnostics Platform (the Platform); the Platform incorporates the SQiDworks™ Integrated Software (the Software). The Platform is a multiplex immunoassay instrument that fully automates the process of a specific IgX PLEX™ Assay from serum transfer to reporting of all assay markers for each individual patient sample. Once the assay's biochemical reactions have completed, the instrument automatically performs a multi-color fluorescent scan of each well in the microarray, analyzes the data, and generates a report containing qualitative results for all assay markers. The SQiDworks Diagnostics Platform also includes numerous internal quality checks and user safety features with fail-safe and interlock mechanisms.
The instrument integrates an automated pipetting station, a fluorescent scanner, washing and drying stations, and other ancillary hardware components using dedicated instrument control. In addition, the software provides scheduling, self-verification, data acquisition, data management, analysis algorithms and reporting software.
Results for each patient sample from the IgX PLEXIM Rheumatoid Arthritis Qualitative Assay and the SQiDworks™ Diagnostics Platform are obtained simultaneously for cach of the three assay markers: RF IgM, RF IgA and CCP IgG using the results from one well containing one aliquot of the patient's serum. Results are reported independently.
The IgX PLEXIM Rheumatoid Arthritis Qualitative Assay (RL1) kit consists of two boxes (with different temperature requirements) of components as described below.
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
Intended for use in clinical laboratories.
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)
A series of nonclinical (in-house) studies were conducted in support of the performance characteristics for the IgX PLEXTM Rheumatoid Arthritis Qualitative Assay and SQiDworks™ Diagnostics Platform. Those characteristics are defined as follows:
- Reproducibility ranges were 95.0%-100% for RF IgA, 96.3%-100% for RF IgM and 83.3%-100% for CCP IgG.
- Clinical sensitivity ranged from 77.7% (CCP IgG) to 93.3% (RF IgM) and clinical specificity ranged from 92.7% (RF IgA) to 96.0% (CCP IgG). This performance is consistent with literature references. In this study, clinical diagnosis (RA or non-RA, including normals) was used as the reference result.
- Overall agreement between the analytes in the IgX PLEX™ Rheumatoid Arthritis Qualitative Assay and established predicate test systems ranged from 85% (RF IgA) to 95% (CCP IgG).
- None of the analytes in the assay were affected by high levels of the following biological substances: bilirubin, hemoglobin, triglycerides and human IgG.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Clinical sensitivity ranged from 77.7% (CCP IgG) to 93.3% (RF IgM) and clinical specificity ranged from 92.7% (RF IgA) to 96.0% (CCP IgG).
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
QUANTA LiteTM RF IgA K983084, QUANTA LiteTM RF IgM K971614, QUANTA LiteTM CCP3 IgG K052264, BioPlex™ 2200 Multi-Analyte Detection System K041658
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.5775 Rheumatoid factor immunological test system.
(a)
Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows a logo for SQI Diagnostics. The logo consists of the letters "SQI" in a stylized font, with the word "DIAGNOSTICS" written vertically to the right of the "I". To the right of the word "DIAGNOSTICS" is a drawing of a drop of liquid, possibly blood.
36 Meteor Drive Toronto ON M9W 1A4 [w] 416.674.9500 [f] 416.674.9300 www.sqidiagnostics.com
SECTION 8 510(K) SUMMARY
OCT 2 9 2009
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is K083080.
807.92 (a)(1):
| Name: | SQI Diagnostics Systems, Inc. | ||
|---|---|---|---|
| Address: | 36 Meteor Drive | ||
| Toronto, Ontario | |||
| Canada M9W 1A4 | |||
| Phone: | 416-674-9500 x239 | ||
| FAX: | 416-674-9300 | ||
| Contact: | Ms. Kate Smith | ||
| Email: | ksmith@sqidiagnostics.com | ||
| 807.92 (a)(2): | Device name- trade name and common name, and classification | ||
| Trade name: | IgX PLEXTM Rheumatoid Arthritis Qualitative Assay and | ||
| SQiDworksTM Diagnostics Platform | |||
| Common Name: | Integrated system for the qualitative detection of IgA and IgM | ||
| Rheumatoid Factors and IgG antibodies to cyclic citrullinated | |||
| peptides in serum samples | |||
| Classification: | Class II | ||
| 21 CFR 866.5775- Rheumatoid Factor Immunological System | |||
| 21 CFR 862.2570- Instrumentation for Clinical Multiplex Test |
1
Image /page/1/Picture/0 description: The image shows the logo for SQI Diagnostics. The logo consists of the letters "SQI" in a stylized font, with the word "DIAGNOSTICS" written vertically to the right of the "I". To the right of the text is a drawing of a water droplet.
36 Meteor Drive oronto ON M9W 1A4 416.674.9500 416.674.9300 www.sqidiagnostics.com
Identification of the legally marketed predicate device 807.92 (a)(3):
The test system is substantially equivalent to other ELISA test kits and microarray systems, specifically the Quanta LITE™ line of reagents (Inova Diagnostics, Inc., San Diego, CA), namely Quanta LITE™ RF IgA ELISA, Quanta LITE™ RF IgM ELISA, and Quanta LITE™ CCP3 IgG ELISA, and the Bioplex™ 2200 Multi-Analyte Detection System (the instrument, Bio-Rad Laboratories, Redmond, WA) respectively.
807.92 (a)(4): Device Description
The device consists of the IgX PLEX™ Rheumatoid Arthritis Qualitative Assay (RL1 kit) and the SQiDworks™ Diagnostics Platform (the Platform); the Platform incorporates the SQiDworks™ Integrated Software (the Software). The Platform is a multiplex immunoassay instrument that fully automates the process of a specific IgX PLEX™ Assay from serum transfer to reporting of all assay markers for each individual patient sample. Once the assay's biochemical reactions have completed, the instrument automatically performs a multi-color fluorescent scan of each well in the microarray, analyzes the data, and generates a report containing qualitative results for all assay markers. The SQiDworks Diagnostics Platform also includes numerous internal quality checks and user safety features with fail-safe and interlock mechanisms.
The instrument integrates an automated pipetting station, a fluorescent scanner, washing and drying stations, and other ancillary hardware components using dedicated instrument control. In addition, the software provides scheduling, self-verification, data acquisition, data management, analysis algorithms and reporting software.
Results for each patient sample from the IgX PLEXIM Rheumatoid Arthritis Qualitative Assay and the SQiDworks™ Diagnostics Platform are obtained simultaneously for cach of the three assay markers: RF IgM, RF IgA and CCP IgG using the results from one well containing one aliquot of the patient's serum. Results are reported independently.
The IgX PLEXIM Rheumatoid Arthritis Qualitative Assay (RL1) kit consists of two boxes (with different temperature requirements) of components as described below.
| Quantity | Container | Volume (each) | Storage | |
|---|---|---|---|---|
| Microarray plate | One (1) | Foil package | 2-8°C | |
| Reporter mix | One (1) | Amber bottle | 15 mL | ≤-15°C |
| Calibrators | Eight (8) | 2.0 mL tube | 400 μL | ≤-15°C |
| Positive Control #1 | One (1) | 2.0 mL tube | 80 μL | ≤-15°C |
| Positive Control #2 | One (1) | 2.0 mL tube | 80 μL | ≤-15°C |
RL1 Kit Components
2
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36 Meteor Drive ronto ON M9W 1A4 1416.674.9500 [] 416.674.9300 ww.saidiaanostics.com
| Negative control | One (1) | 2.0 mL tube | 80 μL | ≤-15°C |
|---|---|---|---|---|
| Sample diluent | One (1) | Translucent bottle | 41 mL | ≤-15°C |
| Wash Buffer | ||||
| Concentrates | Three (3) | Translucent bottle | 42 mL | 2-8°C |
| Documentation and | ||||
| batch-specific | ||||
| calibration | ||||
| information | One (1) per | |||
| shipment | CD-ROM |
IgX PLEX RL1 Microarray Plate
The RL1 microarray plate consists of an array of protein and antibody replicate spots, covalently bound to the surface of coated glass within each well of a standard 96-well assay plate. All wells have the identical configuration of microarray elements, containing:
- . Capture spots for Rheumatoid Factor Fc and CCP.
- Internal normalization curve and control spots for internal consistency . confirmation.
The outer plate holder is labeled with a barcode indicating the assay type and lot number which is read by the platform.
Reporter Mix
The reporter mix is comprised of diluted fluorescently labeled marker antibodies. There is a marker antibody which is specific to each antibody of interest. In the case of the RL1 assay, the labeled markers are anti-human immunoglobulin antibodies (for example mouse o-hIgM). Each type of marker antibody is labeled with a dye in a different spectral range.
Calibrators/Standards
The external calibrators (standards) are eight dilutions of a sample derived from human sera containing an appropriate representation of each of the analytes to be reported. The assay standards (secondary standards) for RF (IgA and IgM) are traceable to the WHO/First British Standard 64/2 (primary standards) and internally calculated in IU/mL. The CCP IgG results are internally calculated in U/mL and are comparable to other assays on the market. The quantitative results are converted to qualitative results (positive and negative), based on assay-specific cutoff values. No. dilutions or reconstitutions are needed.
Controls
The positive and negative control samples are derived from human sera. The platform treats the controls as samples and does not perform any quality assessment based on the
3
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w.sqidiagnostics.com
results. Although expected results for each applicable analyte of each control are provided, each lab is expected to follow their own quality procedures for assessing controls.
Sample Diluent
The sample diluent is a proprietary buffer mix optimized to the requirements of the platform.
Wash Buffer Concentrates
Specific buffer compositions for each wash procedure. The concentrate must be diluted prior to use.
CDROM
One CD is included in each shipment. The contents are a database of lot specific calibration data for each lot in the shipment and the documentation for the user's convenience.
Intended Use 807.92 (a)(5):
The IgX PLEX™ Rheumatoid Arthritis Qualitative Assay and SQiDWorks™M Diagnostics Platform is an in vitro diagnostic test system for the qualitative detection of the IgA and IgM classes of Rheumatoid Factors and the IgG class of anti-cyclic citrullinated peptide antibodies (CCP-proprietary third generation equivalent formulation) in human serum specimens.
The IgX PLEX™ Rheumatoid Arthritis Qualitative Assay is intended for use in clinical laboratories as an aid in the diagnosis of Rheumatoid Arthritis in conjunction with other laboratory and clinical findings, and requires the SQiDworks™ Diagnostics Platform.
4
Image /page/4/Picture/0 description: The image shows the logo for SQI Diagnostics. The logo consists of the letters "SQI" in a stylized font, followed by the word "DIAGNOSTICS" written vertically. To the right of the text is an image of a blood droplet. The logo is black and white.
:
36 Meteor Drive
Toronto ON M9W 1A4
[w] 416.674.9500
[w] 416.674.9500 {f} 416.674.9300 www.sqidiagnostics.com
.
807.92 (a)(6): Technological Similarities and Differences to the Predicate
| IgX PLEXTM Rheumatoid Arthritis Qualitative Assay | Predicate(s) | |
|---|---|---|
| Aspect/Feature/Characteristic | IgX PLEX RF IgA | QUANTA LiteTM RF IgA |
| K983084 | ||
| Intended Use | As aid in diagnosis of rheumatoid | |
| arthritis | Same | |
| Sample Matrix | Serum | Same |
| Methodology | Microarray-based fluorescent | |
| detection | ELISA | |
| Calibration | On each plate | Same |
| Concentration Determination | Qualitative | Semi-Quantitative |
| Expected Value | Cut-off is 12.0 IU/mL | Cut-off is 6 U/mL |
| Assay Substrate | 96-well microarray plates | 96-well microtiter plates |
| Multiplexed Assay | Yes | No |
| Aspect/Feature/Characteristic | IgX PLEX RF IgM | QUANTA LiteTM RF IgM |
| K971614 | ||
| Intended Use | As aid in diagnosis of rheumatoid | |
| arthritis | Same | |
| Sample Matrix | Serum | Same |
| Methodology | Microarray-based fluorescent | |
| detection | ELISA | |
| Calibration | On each plate | Same |
| Concentration Determination | Qualitative | Semi-Quantitative |
| Expected Value | Cut-off is 18.2 IU/mL | Cut-off is 6 U/mL |
| Assay Substrate | 96-well microarray plates | 96-well microtiter plates |
| Multiplexed Assay | Yes | No |
| Aspect/Feature/Characteristic | IgX PLEX Anti-CCP IgG | QUANTA LiteTM CCP3 IgG |
| K052264 | ||
| Intended Use | As aid in diagnosis of rheumatoid | |
| arthritis | Same | |
| Sample Matrix | Serum | Same |
| Methodology | Microarray-based fluorescent | |
| detection | ELISA | |
| Calibration | On each plate | Same |
| Concentration Determination | Qualitative | Semi-Quantitative |
| Expected Value | Cut-off is 11.7 U/mL | Cut-off is 20 U/mL |
| Assay Substrate | 96-well microarray plates | 96-well microtiter plates |
| Multiplexed Assay | Yes | No |
. A R A B T T T T T T T T T T M T R . F . F . F . F . F . F . F . F . F . F . F . F . F . F . F . F . F . F . . . . . . . . . . . . . . . . .
And States Callery
13.80
..............................................................................................................................................................................
And Warry Contractions
2008
5
Image /page/5/Picture/0 description: The image shows the logo for SQI Diagnostics. The logo features the letters "SQI" in a bold, serif typeface, with the word "DIAGNOSTICS" written vertically to the right of the "I". To the right of the text is a detailed illustration of a single drop of liquid, likely representing blood, which is commonly associated with medical diagnostics.
36 Meteor Drive Toronto ON M9W 1A4 [w] 416.674.9500 [f] 416.674.9300 www.sqidiagnostics.com
177 - 13
a
·
| Aspect/Feature/Characteristic | SQiDworks Microarray
Diagnostic Platform | BioPlex™ 2200 Multi-Analyte
Detection System
K041658 |
|--------------------------------|---------------------------------------------------|------------------------------------------------------------|
| Multi-analyte | Yes | Same |
| Multiplexing Method | Based on multiplex microarray
based technology | Based on multiplex,
bead-based technology |
| Detection Type | Fluorescence | Same |
| Target of Detection | Microarray Spot | Bead |
| Detector | Multichannel fluorescence CCD
camera scanner | Laser monochromatic bead flow
cytometry-like reader |
| Sample Handling and Processing | Automated | Same |
| Reagent Storage | No reagent storage | On-board, refrigerated
reagent storage |
| Internal Controls | Blank, serum verification | Same |
| Internal Controls | Reaction condition verifications | No |
| Assay Substrate | 96-well microarray plates | Individual cuvettes |
| Calibration | External calibrators | Same |
| Laboratory Environment | Traditional laboratory
environment | Same |
.
·
்களை முறையும் பயன்படுத்தில் வெளியிட்டுள்ள விளைவிட்டு விடிக்கும் குறிக்கும் புக்கும் புக்கும் புக்கும் புக
6
Image /page/6/Picture/0 description: The image shows the logo for SQI Diagnostics. The logo consists of the letters "SQI" in a bold, serif font, with the word "DIAGNOSTICS" written vertically to the right of the "I". To the right of the text is a stylized image of a teardrop.
6 Meteor Drive onto ON M9W 1A4 416 674 9500 w.sqidiagnostics.com
Brief Description of Nonclinical and Clinical Data 807.92 (b)(1) and (b)(2):
A series of nonclinical (in-house) studies were conducted in support of the performance characteristics for the IgX PLEXTM Rheumatoid Arthritis Qualitative Assay and SQiDworks™ Diagnostics Platform. Those characteristics are defined as follows:
- . Reproducibility ranges were 95.0%-100% for RF IgA, 96.3%-100% for RF IgM and 83.3%-100% for CCP IgG.
- . Clinical sensitivity ranged from 77.7% (CCP IgG) to 93.3% (RF IgM) and clinical specificity ranged from 92.7% (RF IgA) to 96.0% (CCP IgG). This performance is consistent with literature references. In this study, clinical diagnosis (RA or non-RA, including normals) was used as the reference result.
- Overall agreement between the analytes in the IgX PLEX™ Rheumatoid Arthritis . Qualitative Assay and established predicate test systems ranged from 85% (RF IgA) to 95% (CCP IgG).
- . None of the analytes in the assay were affected by high levels of the following biological substances: bilirubin, hemoglobin, triglycerides and human IgG.
807.92 (b)(3): Conclusions from Nonclinical and Clinical Testing
Nonclinical and clinical testing was performed for the IgX PLEX™ Rheumatoid Arthritis Qualitative Assay and SQiDworks™ Diagnostics Platform. The test system was shown to be safe and effective for its intended use.
7
Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure with three flowing lines emanating from it, possibly representing health and well-being.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
SOI Diagnostics Systems c/o Ms. Kate Smith 36 Meteor Drive Toronto, ON Canada M9W 1A4
OCT 2 9 2009
Re: K083080
Trade/Device Name: IgX PLEX™ Rheumatoid Arthritis Qualitative Assay and SQiDworks™ Diagnostics Platform
Regulation Number: 21 CFR §866.5775 Regulation Name: Rheumatoid Factor Immunological System Regulatory Class: Class II Product Code: DHR, NHX, NHX, NSU Dated: October 9, 2009 Received: October 13, 2009
Dear Ms. Smith:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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
8
Page 2 - Ms. Kate Smith
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
ia m chen
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
9
INDICATIONS FOR USE
510(K) Number (if known): K083080
Device Name:
IgX Plex™ Rheumatoid Arthritis Qualitative Assay and SQiDworks™ Diagnostics Platform
Indications for Use:
The IgX PLEX™ Rheumatoid Arthritis Qualitative Assay and SQiDworks™ Diagnostics Platform is an in vitro diagnostic test system for the qualitative detection of the IgA and IgM classes of Rheumatoid Factors, and the IgG class of anti-cyclic citrullinated peptide antibodies (CCPproprietary third generation equivalent formulation) in human serum specimens.
The IgX PLEXTM Rheumatoid Arthritis Qualitative Assay is intended for use in clinical laboratories as an aid in the diagnosis of Rheumatoid Arthritis in conjunction with other laboratory and clinical findings, and requires the SQiDworks™ Diagnostics Platform.
Prescription Use (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Reena Philip
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K083080