(31 days)
Not Found
K/DEN: Not Found
No
The device description and intended use clearly define the product as external controls for a chemical test, not a diagnostic or analytical device utilizing AI/ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No.
This device is an external control set used to verify the performance of other diagnostic tests, not to treat a condition.
No
Explanation: The device is described as an "External Control Set" intended to verify the performance of other diagnostic tests (QuickVue® Advance pH and Amines test or the FemExam® pH and Amines TestCard™) and aid in the interpretation of their results. It does not directly diagnose a condition in a patient; rather, it ensures the accuracy of the diagnostic tools.
No
The device description clearly states that the device is a "buffered solution" and a "set of external controls," indicating it is a physical product, 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 "intended for use as external controls in accordance with the package insert instructions for the QuickVue® Advance pH and Amines test or the FemExam® pH and Amines TestCard™." These tests are themselves IVDs used to diagnose conditions related to vaginal pH and amines. The controls are used with these diagnostic tests.
- Device Description: The description explains that the controls are buffered solutions designed to produce expected color responses when tested with the QuickVue or FemExam tests. This indicates they are used in vitro (outside the body) to evaluate the performance of a diagnostic test.
- Function: The controls are used to "aid in the interpretation of positive and negative test results and verify test and operator performance." This is a key function of controls used in IVD testing.
While the document doesn't explicitly state "In Vitro Diagnostic," the intended use and description clearly align with the definition of an IVD, which is a medical device used to perform tests on samples taken from the human body to help detect, diagnose, monitor, or treat diseases or conditions. In this case, the controls are used to ensure the accuracy and reliability of IVD tests.
N/A
Intended Use / Indications for Use
The pH and Amines External Control Set is intended for use as external controls in accordance with the package insert instructions for the QuickVue® Advance pH and Amines test or the FemExam® pH and Amines TestCard™. When following these instructions, the Controls are to be used in the same manner as a patient swab specimen. For use by healthcare professionals.
The pH and Amines External Control Set is intended for use with the QuickVue® Advance pH and Amines test and the FemExam® pH and Amines TestCard™. These controls are intended for use as external controls to aid in the interpretation of positive and negative test results and verify test and operator performance. The pH and Amines External Control Set is intended for use by healthcare professionals.
Product codes
JJY
Device Description
The Positive Control contains a buffered solution (pH > 4.7 and volatile amines > 0.5mM); the Negative Control contains a buffered solution (pH
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
SEP 2 7 2002
XI. Summary of Safety and Effectiveness
The following information as presented in the Premarket Notification [510(k)] for the pH and Amines External Control Set constitutes data supporting a substantially equivalent determination.
Product:
pH and Amines External Control Set
Manufacturer:
Quidel Corporation 10165 McKellar Court San Diego. California 92121 U.S.A.
Device Classification:
The device, pH and Amines External Control Set, is similar to other FDA-cleared devices which are used in test systems to demonstrate (verify) test performance. The pH and Amines External Control Set falls within the classification of 21 CFR 862.1660.
The Food and Drug Administration has proposed that Quality Control Material (assayed or unassayed) be classified as Class I.
Intended Use:
The pH and Amines External Control Set is intended for use as external controls in accordance with the package insert instructions for the QuickVue® Advance pH and Amines test or the FemExam® pH and Amines TestCard™. When following these instructions, the Controls are to be used in the same manner as a patient swab specimen. For use by healthcare professionals.
Principle of the Controls:
The Positive Control contains a buffered solution (pH > 4.7 and volatile amines > 0.5mM); the Negative Control contains a buffered solution (pH Trade/Device Name: pH and Amines External Control Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: August 26, 2002 Received: August 27, 2002
Dear Ms. Weiner:
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 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 Part 801); 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.
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Page 2 -
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 1 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" (21CFR 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/cdrl/dsmaldsmamain.html".
Sincerely yours,
Steven Putman
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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Indications for Use (Separate Page) XIII.
Page | 1 | of | 1 |
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510(k) Number (if known): | K022851 | ||
Device Name: | pH and Amines External Control Set |
Indications for Use:
The pH and Amines External Control Set is intended for use with the QuickVue® Advance pH and Amines test and the FemExam® pH and Amines TestCard™. These controls are intended for use as external controls to aid in the interpretation of positive and negative test results and verify test and operator performance. The pH and Amines External Control Set is intended for use by healthcare professionals.
(Division Sign-Off)
Division of Clinical Laborato
510(k) Number: K022851
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_**_
(Per 21 CFR 801.109)
OR
Over-The Counter Use_