(29 days)
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No
The document describes a control set for laboratory testing and does not mention any AI or ML components.
No
The device is described as an "Unassayed H. Pylori Control Set," used by laboratories for quality control in immunoassays, not for treating patients.
No
The device is described as a "Control Set" used to estimate precision and systematic shift in accuracy for immunoassays. It is not used to diagnose a condition directly but rather to validate the performance of diagnostic tests.
No
The device description clearly states it is a "Control Set (Positive and Negative Serum Controls)", indicating it is a physical product (serum-based controls) and not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the controls are used by laboratories performing immunoassays for the qualitative determination of Helicobacter pylori IgG antibody in human serum. This is a diagnostic test performed in vitro (outside the body) on a human sample (serum) to provide information about a patient's health status (presence of H. pylori antibodies).
- Device Description: The device is described as a "Control Set" consisting of positive and negative serum controls. Controls are essential components of IVD testing to ensure the accuracy and reliability of the test results.
- Care Setting: The intended user is "laboratories," which are the typical setting for performing IVD tests.
The fact that it's an "Unassayed" control set doesn't change its IVD status. Unassayed controls are still used within the context of an IVD test system to monitor performance.
N/A
Intended Use / Indications for Use
Qualitrol Unassayed H. Pylori Control Set, consisting of positive and negative human serum based controls, may be used by laboratories, performing immunoassays for qualitative determination of Helicobacter pylori IgG antibody in human serum, routinely as a means of estimating precision and systematic shift in accuracy, provided:
(a.) above mentioned controls are used as an adjunct to reagents provided by kit manufacturers and according to the recommended procedure provided specifically for the test system being used by the laboratory;
(b.) above mentioned controls are validated for use with the test system being used:
(c.) above mentioned controls are used in accordance with the quality control requirement of regulatory and/or accrediting organizations and laboratory quality control goals.
Product codes
LYR
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
laboratories
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 866.3110
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).
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Image /page/0/Picture/1 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 three lines forming its body and wings. The eagle is facing right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. William Cone President JUL - 8 1997 Consolidated Technologies, Inc. 2170 Woodward Street Austin, Texas 78744-1832
Re: K972146 Trade Name: Qualitrol Unassayed H. Pylori Control Set (Positive and Negative Serum Controls) Requlatory Class: I Product Code: LYR Dated: June 6, 1997 Received: June 9, 1997
Dear Mr. Cone:
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 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices. Ceneral 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 GMF requlation 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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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) Additionally, for questions on the promotion and 594-4588. 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 at (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
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ધ્યુ ૦૦ ટ
510(k) Number (if known):
Device Name: __Qualitrol Unassayed H. Pylori Control Set Positive and Negative Serum Controls
Indications For Use:
Qualitrol Unassayed H. Pylori Control Set, consisting of positive and negative human serum based controls, may be used by laboratories, performing immunoassays for qualitative determination of Helicobacter pylori IgG antibody in human serum, routinely as a means of estimating precision and systematic shift in accuracy, provided:
(a.) above mentioned controls are used as an adjunct to reagents provided by kit manufacturers and according to the recommended procedure provided specifically for the test system being used by the laboratory;
(b.) above mentioned controls are validated for use with the test system being used:
(c.) above mentioned controls are used in accordance with the quality control requirement of regulatory and/or accrediting organizations and laboratory quality control goals.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Tetti E. Mapin
(Division Sign-Off)
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Division of Clinical Laboratory Device's
510(k) Number
Prescription Use_V (Per 21 CFR 801.109)
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Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)