(268 days)
INTENDED USE: This is an indirect Fluorescent antibody test for the qualitative and semi-quantitative detection of IgG autoantibodies in human serum by manual fluorescent microscopy or with the Image Navigator® Fluorescence SemiAutomated Microscope. This test system is to be used as an aid in the detection of anti-mitochondrial (AMA), antiparietal cell (APCA), and anti-smooth muscle (ASMA) autoantibodies associated with Type 1 Autoimmune Hepatitis, Primary Biliary Cholangitis, and Pernicious Anemia/Autoimmune Gastritis in conjunction with other laboratory and clinical findings. A trained operator must confirm results generated with the Image Navigator® semi-automated device and software.
Not Found
This FDA 510(k) clearance letter for K180202, the HISTOFLUOR RODENT LKS FLUORESCENT ANTIBODY TEST SYSTEM Image Navigator by Immuno Concepts, provides information about its intended use but does not include a detailed description of the acceptance criteria or a study proving that the device meets those criteria, nor does it provide specifics about the test set, ground truth, or training set parameters.
The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory obligations. The "Indications for Use" section describes what the device is intended for (qualitative and semi-quantitative detection of certain autoantibodies) and how it's to be used (manual fluorescent microscopy or with the Image Navigator® Fluorescence Semi-Automated Microscope, with a trained operator confirming results).
Therefore, based solely on the provided text, I cannot complete the requested table and detailed study information. The details about the performance study, acceptance criteria, sample sizes, expert qualifications, and ground truth methodologies would typically be found in the 510(k) submission document itself, which is a much larger and more technical document than this clearance letter.
Here's what can be inferred or stated from the provided text, along with the limitations:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not explicitly stated in the document) | Reported Device Performance (Not explicitly stated in the document) |
|---|---|
| No specific performance metrics or acceptance criteria are provided in this FDA clearance letter. | No specific reported device performance data (e.g., sensitivity, specificity, agreement rates with predicate or gold standard) is provided in this FDA clearance letter. |
| (Typically, acceptance criteria for an IVD would involve demonstrating comparable diagnostic performance to a legally marketed predicate device, often through sensitivity, specificity, and agreement studies. However, these specific targets are absent here.) | (Usually, this section would present quantitative results from clinical or analytical studies comparing the device's output to a reference method or predicate.) |
Information that cannot be determined from the provided FDA clearance letter:
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Cannot be determined from the provided text. The clearance letter does not include details on the study design, sample sizes, or data origin.
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)
- Cannot be determined from the provided text. The letter states that a "trained operator must confirm results generated with the Image Navigator® semi-automated device and software," implying human oversight, but it does not specify the number or qualifications of experts for establishing ground truth during the validation studies.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Cannot be determined from the provided text. No information on adjudication methods is present.
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
- Cannot be determined from the provided text. The letter does not explicitly mention an MRMC study or quantify human performance improvement with AI assistance. It indicates the device can be used with a semi-automated microscope and software, but the impact on human readers is not detailed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Implied not standalone by "A trained operator must confirm results." The text states, "A trained operator must confirm results generated with the Image Navigator® semi-automated device and software." This indicates that the device is intended for use with human-in-the-loop and not as a fully standalone diagnostic tool for final results. Whether a standalone performance evaluation was conducted internally for algorithm development is not stated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be determined from the provided text. While the device aids in detecting autoantibodies associated with specific conditions (Type 1 Autoimmune Hepatitis, Primary Biliary Cholangitis, and Pernicious Anemia/Autoimmune Gastritis) "in conjunction with other laboratory and clinical findings," the specific method for establishing ground truth in the device's validation studies is not described.
8. The sample size for the training set
- Cannot be determined from the provided text. Information about the training set size is not included in this document.
9. How the ground truth for the training set was established
- Cannot be determined from the provided text. No details are provided regarding the establishment of ground truth for any training data used for the device's algorithm.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 19, 2018
Immuno Concepts, N.A., Ltd. Eric Hoy Chief Scientific Officer 9825 Goethe Road, Suite 350 Sacramento, California 95827
Re: K180202
Trade/Device Name: Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: DBL, PIV Dated: September 19, 2018 Received: September 20, 2018
Dear Eric Hoy:
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 mav, 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 avare 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Douglas A. Jeffery -S
For,
Lea Carrington Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement below. |
|---|---|
| ------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------- |
Indications for Use
| 510(k) Number (if known) | K180202 |
|---|---|
| Device Name | HISTOFLUOR RODENT LKS FLUORESCENT ANTIBODY TEST SYSTEMImage Navigator by Immuno Concepts |
| Indications for Use (Describe) |
INTENDED USE: This is an indirect Fluorescent antibody test for the qualitative and semi-quantitative detection of IgG
autoantibodies in human serum by manual fluorescent microscopy or with the Image Navigator® Fluorescence
SemiAutomated Microscope. This test system is to be used as an aid in the detection of anti-mitochondrial (AMA),
antiparietal cell (APCA), and anti-smooth muscle (ASMA) autoantibodies associated with Type 1 Autoimmune Hepatitis,
Primary Biliary Cholangitis, and Pernicious Anemia/Autoimmune Gastritis in conjunction with other laboratory and
clinical findings. A trained operator must confirm results generated with the Image Navigator® semi-automated device
and software.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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
"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."
FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740
and the comments of the state of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the contribution of the consi
Comments of Children
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
:
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).