(140 days)
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Not Found
No
The summary describes a standard in vitro diagnostic assay (EIA) for detecting a specific antigen, with no mention of AI, ML, image processing, or any computational analysis beyond typical assay interpretation.
No
The device is an in vitro diagnostic assay used to detect specific antigens to aid in diagnosis, not to provide therapy or treatment.
Yes
The device is intended for use "as an aid in the diagnosis of Campylobacter infections," which clearly indicates its role in diagnosing a condition.
No
The device description clearly states it is an "in vitro microplate EIA," which is a laboratory assay involving physical reagents and equipment, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is an "in vitro microplate EIA for the qualitative detection of Campylobacter Specific Antigen in fecal specimens and broth enriched fecal cultures." The term "in vitro" means "in glass" or "in the lab," referring to tests performed outside of the living body.
- Device Description: The "Device Description" also uses the phrase "in vitro microplate EIA."
- Purpose: The intended use is to aid in the diagnosis of Campylobacter infections by detecting a specific antigen in a biological sample (fecal specimens). This is a classic function of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ProSpecT® Campylobacter Microplate Assay is an in vitro microplate EIA for the qualitative detection of Campylobacter Specific Antigen in fecal specimens and broth enriched fecal cultures. ProSpecT Campylobacter Microplate Assay is intended for use as an aid in the diagnosis of Campylobacter infections.
Product codes
LQP
Device Description
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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
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§ 866.3110
Campylobacter fetus serological reagents.(a)
Identification. Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identifyCampylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases.Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.(b)
Classification. Class I (general controls).
0
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement. The logo is black and white.
NOV 1 8 100
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Ken Hood Director of Regulatory Affairs Alexon-Trend, Inc. 14000 Unity Street NW Ramsey, Minnesota 55303-9115
Re: K982315/S2
ProSpecT® Campylobacter Microplate Assay Trade Name: Requlatory Class: I Product Code: LQP Dated: November 2, 1998 Received: November 3, 1998
Dear Mr. Hood:
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 Requlations, 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 regulatory action. In addition, FDA may publish further 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 Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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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" (21 CFR 807.97). Other general information on your 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/dsma/dsmamain.html".
Sincerely yours,
Steven Gutman
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
2
510 (k) Number K982315
Device Name: ProSpecT® Campylobacter Microplate Assay
INDICATIONS FOR USE:
The ProSpecT® Campylobacter Microplate Assay is an in vitro microplate EIA for the qualitative detection of Campylobacter Specific Antigen in fecal specimens and broth enriched fecal cultures. ProSpecT Campylobacter Microplate Assay is intended for use as an aid in the diagnosis of Campylobacter infections.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Woody Defors | |
|---|---|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K98 2315 |
Prescription Use (Per 21 CFR 801.109)
OR
Over-The Counter Use __
( Optional Format 1-2-96)