(93 days)
The QUANTA Lite™ RNA Pol III ELISA is a semiquantitative enzyme-linked immunosorbent assay for the detection of IgG anti-RNA Polymerase III antibodies in patient sera. The presence of these antibodies, when considered in conjunction with other laboratory and clinical findings, is an aid in the diagnosis of systemic sclerosis (scleroderma) with increased incidence of skin involvement and renal crisis.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for the QUANTA Lite™ RNA Polymerase III device. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the detailed study information, acceptance criteria, or performance data typically included in a study report or clinical trial summary.
Therefore, I cannot fully complete your request based solely on the provided text. The letter confirms the device's regulatory status and intended use but does not elaborate on the specific study details you've asked for.
To address your request, I will extract the information that is available and indicate where the requested information is not provided in this document.
Here's an attempt to answer your questions based on the provided FDA letter:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided | Not provided |
Explanation: This letter is an FDA clearance letter, not a detailed study report. It does not contain specific acceptance criteria or performance metrics (like sensitivity, specificity, accuracy) used in the validation study. It only states that the device was found "substantially equivalent" to predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not provided.
- Data Provenance (e.g., country of origin): Not provided.
- Retrospective or Prospective: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not provided.
- Qualifications of Experts: Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This device, the QUANTA Lite™ RNA Polymerase III ELISA, is an in vitro diagnostic (IVD) immunoassay for detecting antibodies, not an AI-powered image analysis tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This is an immunoassay kit. Its "performance" would be evaluated in a standalone manner (i.e., the assay itself produces results), but the concept of "algorithm only without human-in-the-loop performance" as typically applied to AI/software clinical decision support systems is not directly applicable here. The device performs its function to detect antibodies, and the results are then interpreted by a healthcare professional in conjunction with other clinical findings. The study would have evaluated the analytical and clinical performance of the assay itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
-
For an immunoassay like this, the ground truth for clinical performance studies would typically involve:
- Clinical diagnosis: Confirmation of systemic sclerosis (scleroderma) based on established clinical criteria (e.g., ACR/EULAR criteria).
- Reference laboratory methods: Comparison to a gold standard or well-established reference method for RNA Polymerase III antibodies, if one exists and is widely accepted.
- Patient outcomes data: While not the primary ground truth for assay performance, patient outcomes (e.g., progression of skin involvement, renal crisis) are relevant for validating the clinical utility of the antibody as an "aid in diagnosis."
-
Specifics in the document: Not provided.
8. The sample size for the training set
- Sample Size for Training Set: Not provided. (This device is an immunoassay, not a machine learning algorithm that typically undergoes a distinct "training" phase in the same way. Its development would involve assay optimization and validation.)
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable in the context of a machine learning training set for this type of IVD immunoassay. Assay development and optimization involve extensive analytical and clinical validation, but not "training" in the AI sense.
Summary of missing information:
The provided document is an FDA 510(k) clearance letter. It confirms regulatory approval based on "substantial equivalence" but does not contain the detailed technical and clinical study data (acceptance criteria, performance metrics, sample sizes, ground truth methodology, expert qualification, adjudication methods) that would be found in a full study report or the 510(k) submission itself. To get that level of detail, one would typically need to review the actual 510(k) submission available through FDA databases or directly from the manufacturer.
{0}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes, possibly representing health, services, and the people they serve. The logo is in black and white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
INOVA Diagnostics, Inc. c/o Mr. Brys Myers Vice President 9900 Old Grove Road San Diego, CA 92131-1234
APR 1 1 2007
Re: K070066
Trade/Device Name: QUANTA Lite™ RNA Polymerase III Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear antibody immunological test system Regulatory Class: Class II Product Code: NYO Dated: March 12, 2007 Received: March 14, 2007
Dear Mr. Myers:
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 either class II (Special Controls) or class III (PMA), it may be subject to such 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The
{1}------------------------------------------------
Page 2 -
FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, 11 Juastions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Robert K. Beckerf
Robert L. Becker, Jr., M.D., 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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ K070066
Device Name:__________________________________________________________________________________________________________________________________________________________________ QUANTA Lite RNA Polymerase III
Indications For Use: The QUANTA Lite™ RNA Pol III ELISA is a semiquantitative enzyme-linked immunosorbent assay for the detection of IgG anti-RNA Polymerase III antibodies in patient sera. The presence of these antibodies, when considered in conjunction with other laboratory and clinical findings, is an aid in the diagnosis of systemic sclerosis (scleroderma) with increased incidence of skin involvement and renal crisis.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Maria M. Chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of
510(k) K070066
§ 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).