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.

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 < 4.7 and volatile amines < 0.5 mM). The pH and Amines External Control Set will produce examples of the color response to be expected for negative and positive specimens when tested with the QuickVue Advance pH and Amines test or 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.

AI/ML Overview

The provided text describes a medical device, the "pH and Amines External Control Set", and its regulatory approval process, specifically focusing on its substantial equivalence to other marketed devices. However, the document does not present a typical study design with acceptance criteria and device performance metrics in the way one would expect for a diagnostic or therapeutic device.

Instead, the "studies" mentioned are related to the manufacturing and design of the control set to ensure it performs as intended to verify other test systems.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics (e.g., sensitivity, specificity, accuracy) for the pH and Amines External Control Set in the context of a clinical study. The criteria and performance mentioned are related to the manufacturing quality and functional equivalence of the control set itself.

Acceptance Criteria (Implied)	Reported Device Performance
Similarity to other commercially available controls: In terms of features and intended use.	The pH and Amines External Control Set was shown to be similar to other commercially available controls in terms of features and intended use.
Inter-assay precision: The ability of the controls to produce consistent results across different assays.	Demonstrated that the Controls could be manufactured reproducibility for reliable performance in the QuickVue® Advance pH and Amines test or the FemExam® pH and Amines TestCard™.
Intra-assay precision: The ability of the controls to produce consistent results within the same assay.	Demonstrated that the Controls could be manufactured reproducibility for reliable performance in the QuickVue® Advance pH and Amines test or the FemExam® pH and Amines TestCard™.
Lot-to-lot consistency: The ability of different manufacturing lots of the controls to produce consistent results.	Demonstrated that the Controls could be manufactured reproducibility for reliable performance in the QuickVue® Advance pH and Amines test or the FemExam® pH and Amines TestCard™.

2. Sample sized used for the test set and the data provenance

Test set sample size: Not explicitly stated. The studies described appear to be more about manufacturing quality control and comparison to predicate devices, rather than a clinical test set in the traditional diagnostic sense.
Data provenance: Not specified. The studies were undertaken by the manufacturer, Quidel Corporation. Given the nature of a 510(k) submission, these would likely be internal studies. There is no mention of country of origin for data or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is an external control set for other diagnostic tests, not a diagnostic device itself that produces a clinical result requiring expert interpretation for ground truth. The "ground truth" for the controls themselves is their chemical composition (pH and amine levels) and their ability to elicit expected color responses from the diagnostic tests they are designed to control.

4. Adjudication method for the test set

Not applicable. There is no mention of expert adjudication for a test set, as the studies are focused on the manufacturing and functional performance of the control set itself.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The device is a "pH and Amines External Control Set," which is a quality control material, not a diagnostic or AI-powered device. Therefore, MRMC studies and assessment of human reader improvement with or without AI assistance are not relevant to this product.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the pH and Amines External Control Set is based on its chemical composition:

Positive Control: Buffered solution with pH > 4.7 and volatile amines > 0.5mM.
Negative Control: Buffered solution with pH < 4.7 and volatile amines < 0.5 mM.

Its effectiveness is gauged by its ability to produce the expected color response when used with the QuickVue® Advance pH and Amines test or the FemExam® pH and Amines TestCard™. This is a functional ground truth based on the chemical properties of the controls and the established response of the diagnostic tests they are validating.

8. The sample size for the training set

Not applicable. This is a quality control material, not a device developed using machine learning or requiring a training set in that context.

9. How the ground truth for the training set was established

Not applicable.

Summary

{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:

Principle of the Controls:

{1}------------------------------------------------

Safety and Effectiveness:

Numerous studies were undertaken to document the performance characteristics and the substantial equivalence of the pH and Amines External Control Set to other commercially available products. These studies include the following:

1. The pH and Amines External Control Set was shown to be similar to other commercially available controls in terms of features and intended use.
1. Inter- and intra-assay precision analysis and lot-to-lot consistency demonstrated that the Controls could be manufactured reproducibility for reliable performance in the QuickVue Advance pH and Amines test or the FemExam pH and Amines TestCard.

Conclusion:

These studies demonstrated the substantial equivalence of the pH and Amines External Control Set to existing products already marketed. They further demonstrated the suitability of the product for laboratory and professional use. Such studies are a critical element in establishing the fundamental safety and effectiveness of the product and its appropriateness for commercial distribution.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, composed of three curved lines that suggest a head, torso, and legs. The figure is oriented to the right. Arcing around the top and left side of the figure is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 2 7 2002

Ms. Robin Weiner Vice President Clinical and Regulatory Affairs Quidel Corporation 10165 McKellar Court San Diego. CA 92121

Re: K022851

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.

{3}------------------------------------------------

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

{4}------------------------------------------------

Indications for Use (Separate Page) XIII.

Page	1	of	1
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)

Over-The Counter Use_

Regulation Number and Section

§ 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.