(177 days)
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No
The summary describes a rapid immunochromatographic assay, which is a traditional diagnostic method and does not mention any AI/ML components or image processing.
No.
The device is described as a qualitative, in vitro immunochromatographic assay for the rapid detection of Leishmania species antigen in ulcerative skin lesions, intended to aid in the diagnosis of Cutaneous Leishmaniasis (CL), not to treat it.
Yes
Explanation: The device is described as an "immunochromatographic assay for the rapid detection of Leishmania species antigen" which is intended to "aid in the diagnosis of CL". This clearly indicates its use in identifying a medical condition, which is the definition of a diagnostic device.
No
The device is described as an "in vitro immunochromatographic assay," which is a laboratory test involving physical components (test strips, reagents, etc.) and is not solely software.
Yes, based on the provided information, the CL Detect™ Rapid Test is an IVD (In Vitro Diagnostic).
Here's why:
- "in vitro immunochromatographic assay": This explicitly states that the test is performed in vitro (outside of the body).
- "for the rapid detection of Leishmania species antigen in ulcerative skin lesions": This describes the purpose of the test, which is to detect a substance (antigen) in a biological sample (from skin lesions).
- "intended for use with dental broach samples": This further clarifies that the test uses a sample taken from the patient.
- "To aid in the diagnosis of CL": This indicates the clinical purpose of the test, which is to provide information for diagnosis.
All of these characteristics align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CL Detect™ Rapid Test is a qualitative, in vitro immunochromatographic assay for the rapid detection of Leishmania species antigen in ulcerative skin lesions. The test is intended for use with dental broach samples from less than four month old ulcerative skin lesions that are obtained from patients with suspected cutaneous leishmaniasis (CL). The test targets the peroxidoxin antigen of Leishmania species that may cause CL. The CL DetectTM Rapid To aid in the diagnosis of CL, and must be interpreted within the context of all relevant clinical and laboratory findings.
Product codes
PIT
Device Description
The CL Detect™ Rapid Test is a qualitative, in vitro immunochromatographic assay for the rapid detection of Leishmania species antigen in ulcerative skin lesions. The test targets the peroxidoxin antigen of Leishmania species that may cause CL.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
ulcerative skin lesions
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.3870
Trypanosoma spp. serological reagents.(a)
Identification. Trypanosoma spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toTrypanosoma spp. in serum. The identification aids in the diagnosis of trypanosomiasis, a disease caused by parasitic protozoans belonging to the genusTrypanosoma. Trypanosomiasis in adults is a chronic disease characterized by fever, chills, headache, and vomiting. Central nervous system involvement produces typical sleeping sickness syndrome: physical exhaustion, inability to eat, tissue wasting, and eventual death. Chagas disease, an acute form of trypanosomiasis in children, most seriously affects the central nervous system and heart muscle.(b)
Classification. Class I (general controls).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
INBIOS INTERNATIONAL INC. ESTELA RAYCHAUDHURI PRESIDENT 562 1ST AVE. SOUTH, STE 600 SEATTLE WA 98104
November 14, 2014
Re: K141341
Trade/Device Name: CL Detect™ Rapid Test Regulation Number: 21 CFR 866.3870 Regulation Name: Trypanosoma spp. serological reagents Regulatory Class: I Product Code: PIT Dated: October 21, 2014 Received: October 22, 2014
Dear Ms. Raychaudhuri:
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 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.
1
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/Resourcesfor You/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,
Uwe Scherf - S for
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology 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) K141341
Device Name CL Detect™ Rapid Test
Indications for Use (Describe)
The CL Detect™ Rapid Test is a qualitative, in vitro immunochromatographic assay for the rapid detection of Leishmania species antigen in ulcerative skin lesions. The test is intended for use with dental broach samples from less than four month old ulcerative skin lesions that are obtained from patients with suspected cutaneous leishmaniasis (CL). The test targets the peroxidoxin antigen of Leishmania species that may cause CL. The CL DetectTM Rapid To aid in the diagnosis of CL, and must be interpreted within the context of all relevant clinical and laboratory findings.
| 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) |
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