(77 days)
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No
The summary describes a standard enzyme immunoassay and an automated microplate analyzer, neither of which are described as using AI or ML. The performance studies focus on correlation between manual and automated methods, not on AI/ML model performance.
No
This device is an in vitro diagnostic test designed to detect C. difficile toxins in fecal specimens, not to treat or prevent a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states "FOR IN VITRO DIAGNOSTIC USE", indicating its purpose is to diagnose C. difficile disease.
No
The device is an in vitro diagnostic test kit, which is a physical product containing reagents and other materials for performing a laboratory test. While it can be used with an automated analyzer (which likely involves software), the core device itself is a hardware/reagent-based assay.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "FOR IN VITRO DIAGNOSTIC USE."
- Nature of the Test: The test is an enzyme immunoassay designed to detect specific substances (toxins A and B) in a biological sample (fecal specimens) to aid in the diagnosis of a disease (C. difficile disease). This is the core function of an in vitro diagnostic device.
- Sample Type: The test is performed on "fecal specimens," which are biological samples taken from the body and tested in vitro (outside the body).
N/A
Intended Use / Indications for Use
The C. DIFFICILE TOX A/B II test is an enzyme immunoassay for the detection of toxins A and B produced by toxigenic strains of Clostridium difficile in fecal specimens from persons suspected of having C. difficile disease and results should be considered in conjunction with the patient history. The test may be performed using either manual or automated (PersonalLab Junior, Adaltis U.S. Inc.) methods. FOR IN VITRO DIAGNOSTIC USE.
Product codes (comma separated list FDA assigned to the subject device)
LLH
Device Description
The C. DIFFICILE TOX A/B II test is an enzyme-linked immunoassay for the detection of toxins A and B in fecal specimens from patients suspected of having C. difficile disease and can be used either manually or with the Adaltis Personal Lab Jr. automated microplate analyzer system for ease of use. The subject test kit is an enzyme-linked immunoassay and has not been modified from the predicate device (K003306 and K971182). It has no technological differences from the prior 510(k) applications. The automated microplate analyzer system was not modified for use with this assay. The K971761 510(k) describes the software validation study, which has not been modified for this assay.
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
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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
The C. DIFFICILE TOX A/B II test was tested with pre-characterized fecal samples both manually and with four of the same model of automated microplate analyzer system by three different people.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of these evaluations show a positive sample correlation of > 97% and a negative sample correlation of > 99% between the manual and automated methods.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
positive sample correlation of > 97% and a negative sample correlation of > 99%
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.
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.
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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).
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§ 866.2660 Microorganism differentiation and identification device.
(a)
Identification. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
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APR 2 5 2003
Summary of Safety and Effectiveness
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: K030404.
This product, C. DIFFICILE TOX A/B II test, was used with the Adaltis Personal Lab Jr, automated microplate analyzer system.
The equivalent predicate device 510(k) numbers are K003306, K971182, and K971761 respectively.
The C. DIFFICILE TOX A/B II test is an enzyme-linked immunoassay for the detection of toxins A and B in fecal specimens from patients suspected of having C. difficile disease and can be used either manually or with the Adaltis Personal Lab Jr. automated microplate analyzer system for ease of use.
The subject test kit is an enzyme-linked immunoassay and has not been modified from the predicate device (K003306 and K971182). It has no technological differences from the prior 510(k) applications.
The automated microplate analyzer system was not modified for use with this assay. The K971761 510(k) describes the software validation study, which has not been modified for this assay.
The C. DIFFICILE TOX A/B II test was tested with pre-characterized fecal samples both manually and with four of the same model of automated microplate analyzer system by three different people. The results of these evaluations show a positive sample correlation of > 97% and a negative sample correlation of > 99% between the manual and automated methods.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Public Health Service
APR 2 5 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. David A. Wall Vice-President of Operations TECHLAB, Inc. VPI Research Park 1861 Pratt Drive, Suite 1030 Blacksburg, VA 24060-6364
K030404 Re:
Trade/Device Name: C. Difficile Tox A/B II Regulation Number: 21 CFR 866.2660 Regulation Name: Microorganism Differentiation and Identification Device Regulatory Class: Class I Product Code: LLH Dated: February 5, 2003 Received: February 6, 2003
Dear Mr. Wall:
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 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 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The 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, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INTENDED USE 2.0
510(k) Number (if known): K 30404 . . . - -
Device Name: C. DIFFICILE TOX A/B II
Indications For Use:
The C. DIFFICILE TOX A/B II test is an enzyme immunoassay for the detection of toxins A and B produced by toxigenic strains of Clostridium difficile in fecal specimens from persons suspected of having C. difficile disease and results should be considered in conjunction with the patient history. The test may be performed using either manual or automated (PersonalLab Junior, Adaltis U.S. Inc.) methods. FOR IN VITRO DIAGNOSTIC USE.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Luddite Cooley
Prescription Use V (Per 21 CFR 801.109)
Over-The Counter Use Division Sian Off Division of Clinical Laboratory Devices 510(k) Number_ L(0 30404 (Optional format 1-2-96)