(30 days)
No
The device description details a standard enzyme immunoassay (EIA) process involving antibody binding, washing steps, and spectrophotometric quantification. There is no mention of AI, ML, or any computational analysis beyond basic comparison to controls.
No
This device is an in vitro diagnostic test for the qualitative detection of Clostridium difficile Toxin A, which aids in diagnosis rather than providing therapy.
Yes
This device is intended for the "qualitative detection of Clostridium difficile Toxin A in human fecal specimens as an aid in the diagnosis of Clostridium difficile-associated diseases." The purpose of aiding in diagnosis clearly indicates it is a diagnostic device.
No
The device description clearly outlines a laboratory-based enzyme immunoassay (EIA) kit involving physical reagents, microwell strips, washing steps, and spectrophotometric analysis, indicating it is a hardware-based diagnostic test, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of Clostridium difficile Toxin A in human fecal specimens." This involves testing a sample taken from the human body (in vitro) to provide information about a disease state.
- Device Description: The description details a laboratory-based assay using microwell strips, antibodies, and enzymatic reactions to analyze a fecal sample. This is a typical format for an in vitro diagnostic test.
- Anatomical Site: The sample is taken from "human fecal specimens," which is a biological sample from the human body.
The core function of the device is to analyze a biological sample outside of the body to aid in the diagnosis of a disease, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Bartels Clostridium difficile Toxin A Enzyme Immunoassay (EIA) is intended for the qualitative detection of Clostridium difficile Toxin A in human fecal specimens as an aid in the diagnosis of Clostridium difficile-associated disease.
Product codes
LLH
Device Description
The Bartels Clostridium difficile Toxin A EIA is a rapid method for the diagnosis of Clostridium difficile toxin A in human fecal samples, to be used as an aid in the detection of Clostridium difficile-associated disease. Microwell strips are coated with mouse IgG to Clostridium difficile toxin A, which selectively captures Clostridium difficile toxin A if present in a stool sample. Irrelevant specimen debris, including non-toxigenic strains of Clostridium difficile, is washed away. Rabbit immunoglobulins to Clostridium difficile toxin A and peroxidase-labeled goat anti-rabbit antibodies are added to the well concurrently in a coincubation step. During incubation, the rabbit anti- Clostridium difficile toxin A binds to captured toxin A. Peroxidase-labeled anti-rabbit antibodies bind to rabbit antitoxin, forming an antitoxin-conjugate complex. Unbound anti-toxin and conjugate are washed away. Solution 3 and Solution 4 are then added and color is produced if the antitoxin-conjugate complex, which possesses the enzyme for the substrate (HRP), is present. This color production is quantified spectrophotometrically and compared to negative and positive controls for determination of the presence of Clostridium difficile toxin A.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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Image /page/0/Picture/0 description: The image shows the date 3/3/99 and the text "Bartels Clostridium difficile Toxin A EIA Special 510(k) Modification". The date is written in a handwritten style, with the year 1999 abbreviated to 99. The text below the date describes a medical product or test, likely related to Clostridium difficile toxin A.
K990664 000017
Confidential
510(K) SUMMARY
CONTACTS A.
MANUFACTURING SITE:
Candice DiDominick Compliance Manager INTRACEL Corporation 2005 NW Sammamish Road, Suite 107 Issaquah, Washington 98027
Phone: (425) 392-2992 ext. 638 Fax: (425) 557-1894
INTRACEL -ROCKVILLE
Cecilia Matos-Rosa Regulatory Compliance INTRACEL Corporation 1330 Piccard Drive Rockville, MD 20850
Phone: (301) 258-5200 ext. 1124 (301) 977-3229 Fax:
NAME OF DEVICE AND CLASSIFICATION B.
Bartels PRIMA System™ Clostridium difficile Toxin A Enzyme Immunoassay (EIA).
Trade/Proprietary Name:
PRIMA System – old Bartels ELISA - new
Device Class:
Class I
510(k): K913229
1
C. LEGALLY MARKETED DEVICE
Bartels Clostridium difficile Toxin A EIA claims substantial equivalence to Bartels PRIMA System Clostridium difficile Toxin A EIA (K913229), currently in commercial distribution by INTRACEL, Corporation, Issaquah, WA (USA).
DEVICE DESCRIPTION: D.
The Bartels Clostridium difficile Toxin A EIA is a rapid method for the diagnosis of Clostridium difficile toxin A in human fecal samples, to be used as an aid in the detection of Clostridium difficile-associated disease. Microwell strips are coated with mouse IgG to Clostridium difficile toxin A, which selectively captures Clostridium difficile toxin A if present in a stool sample. Irrelevant specimen debris, including non-toxigenic strains of Clostridium difficile, is washed away. Rabbit immunoglobulins to Clostridium difficile toxin A and peroxidase-labeled goat anti-rabbit antibodies are added to the well concurrently in a coincubation step. During incubation, the rabbit anti- Clostridium difficile toxin A binds to captured toxin A. Peroxidase-labeled anti-rabbit antibodies bind to rabbit antitoxin, forming an antitoxin-conjugate complex. Unbound anti-toxin and conjugate are washed away. Solution 3 and Solution 4 are then added and color is produced if the antitoxin-conjugate complex, which possesses the enzyme for the substrate (HRP), is present. This color production is quantified spectrophotometrically and compared to negative and positive controls for determination of the presence of Clostridium difficile toxin A.
INTENDED USE STATEMENT E.
Bartels Clostridium difficile Toxin A Enzyme Immunoassay (EIA) is intended for the qualitative detection of Clostridium difficile Toxin A in human fecal specimens as an aid in the diagnosis of Clostridium difficile -associate diseases.
DESCRIPTION OF MODIFIED DEVICE COMPARED TO CLEARED F. DEVICE
INTRACEL has made no changes to the manufacturing process or quality control testing procedures for this product. The only changes relate to the incubation and washing conditions employed during performance of the immunoassay. The essential immunoreagents, underlying format and scientific principle remain the same with the improved product.
The following changes have been made for the kit assay procedure:
- 1 . In the FDA cleared kit, the specimen is incubated in the antibodycoated well for 90 minutes at 37° C. In the improved format, the specimen is now incubated for only 30 minutes at 37° C.
2
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- In the FDA cleared kit, the product insert only specifies the use of an automated microwell washer after sample and conjugate incubation steps. In the improved format, the wash can also be conducted using a manual method. The manual wash procedure is being incorporated into the procedure in reaction to actual use conditions by the customers. The total number of washes remains at 4 for both procedures.
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- In the FDA cleared kit, the colorimetric substrate is incubated for 15 minutes at ambient temperature. In the improved assay procedure, the substrate is incubated for 30 minutes at 37℃.
To summarize, the total assay time is reduced from 135 minutes to 90 minutes. All incubation times are now performed at 37°C, and an alternative manual washing method was added.
3
Public Health Service
Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, with three human figures in the negative space between the wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
MAR 3 1 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Cecilia Matos-Rosa Regulatory Compliance INTRACEL Corporation 1330 Piccard Drive Rockville, MD 20850
Re : K990664 Trade Name: Bartels PRIMA System Clostridium difficile Toxin A Enzyme Immunoassay (EIA) Regulatory Class: I Product Code: LLH Dated: March 1, 1999 Received: March 1, 1999
Dear Ms. Matos-Rosa:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in In addition, FDA may publish further regulatory action. announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the
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Page 2 -
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" Other general information on your (21 CFR 807.97). responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
006003
510(k) Number (if known): K990664
Device Name: Bartels Clostridium difficile Toxin A EIA
Indications For Use:
Bartels Clostridium difficille Toxin A Enzyme Immunoassay (EIA) is intended for the qualitative detection of Clostridium difficille Toxin A in human fecal specimens as an aid in the diagnosis of Clostridium difficilleassociated disease.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Woody Dubois
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K990664
Image /page/5/Picture/8 description: The image shows the words "Prescription Use" in bold font, followed by the text "(Per 21 CFR 801.109)" in a smaller font. There is a line under the words "Prescription Use" with a large X drawn over the line. The text is left-aligned and appears to be part of a form or document.
OR
(Optional Format 1-2-96)