The CARDS® Q.S.® hCG Serum/Urine (also sold under the brand name Concise® Performance Plus™ hCG-Combo) is a one-step immunoassay intended for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early detection of pregnancy. The test is intended for use by health care professionals.

Device Description

The device, CARDS Q.S. hCG Serum/Urine (also sold under the brand name Concise Performance Plus hCG-Combo), is similar to other FDA-cleared devices used for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine. The test is used in the early detection of pregnancy and is intended to measure hCG, a placental hormone, in serum, plasma or urine (21 CFR 862.1155). The FDA has proposed that hCG test systems be classified as Class II.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the CARDS® Q.S.® hCG Serum/Urine and Concise® Performance Plus™ hCG-Combo device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative "acceptance criteria" with specific numerical thresholds prior to testing. Instead, it describes general performance characteristics that were demonstrated. The reported device performance is based on fulfilling these general characteristics.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to other FDA-cleared devices	The test was shown to be similar to other commercially distributed in vitro tests in terms of features and intended use. Demonstrated substantial equivalence to existing products already marketed.
Excellent precision (intra- and inter-assay)	The test was shown to have excellent intra- and inter-assay precision.
Reproducible manufacturability (Lot-to-lot consistency)	Lot-to-lot consistency analyses showed the test to be reproducibly manufacturable.
No interference from common substances	Common drugs, chemicals, and biologicals were shown not to interfere with the test's performance.
High accuracy compared to a predicate device	Using samples obtained from women presenting for pregnancy testing, a direct comparison of the test to another FDA-cleared device for qualitative hCG detection was conducted. An accuracy exceeding 99% was observed.
Suitability for use by healthcare professionals (including POLs)	Physician's Office Laboratory (POL) studies were conducted to show that doctor's office personnel with diverse educational backgrounds and work experience could perform the test accurately and reproducibly. Testing was performed at three geographically distinct sites in the United States. The results obtained at each site agreed greater than 100% with the expected results (this suggests perfect agreement with the "expected results" for the POL studies, rather than a direct comparison to a predicate like the accuracy study). The studies "demonstrated the suitability of the product for use by health care professionals."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact sample size for the "direct comparison" accuracy study. It mentions "samples obtained from women presenting for pregnancy testing."
Data Provenance:
- Country of Origin: Not explicitly stated for all samples, but the Physician's Office Laboratory (POL) studies were conducted at "three geographically distinct sites in the United States."
- Retrospective or Prospective: Not explicitly stated, but the description "samples obtained from women presenting for pregnancy testing" often implies a prospective collection, or at least a collection of residual diagnostic samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide details on the number or qualifications of experts used to establish the ground truth.

For the accuracy study, the comparison was made against "another FDA-cleared device for qualitative hCG detection," implying that the ground truth was essentially the result from this predicate device. It doesn't describe an expert panel reviewing cases for ground truth.
For the POL studies, the results were compared to "expected results," which likely refers to a gold standard produced by specialized lab personnel or the predicate device, rather than expert interpretation of each case.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1). The primary comparison methodology was a direct comparison to another FDA-cleared device, and for POL studies, against "expected results."

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

This is not applicable to the provided document. The device is a qualitative diagnostic immunoassay (hCG test), not an AI-assisted diagnostic tool that involves human readers interpreting images or complex data. Therefore, an MRMC study and AI assistance effect size are not relevant here.

6. If a Standalone (Algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is an immunoassay that produces a visual result (a plus or minus sign). While it can be interpreted as an "algorithm" in a very broad sense, it's a chemical test, not a computational algorithm that performs standalone analysis. The "human-in-the-loop" aspect for this device is simply the user performing the test and reading the visual result. The Physician's Office Laboratory (POL) studies assess this human interpretation in a real-world setting.

7. The Type of Ground Truth Used

For the accuracy study: The ground truth was established by the results of "another FDA-cleared device for qualitative hCG detection." This effectively means a predicate device's result was used as the reference standard.
For the POL studies: The results were compared to "expected results," which again implies a reference standard, likely from a central lab or the predicate device, rather than a pathology report or direct outcomes data in the usual sense.

8. The Sample Size for the Training Set

The document does not explicitly describe a "training set" in the context of a machine learning model. This is an immunoassay device, not an AI or machine learning product. Therefore, the concept of a training set as commonly understood in AI development does not apply here. The document describes studies to demonstrate performance and equivalence, which are akin to validation studies.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" in the context of an AI/ML product, this question is not applicable. The device's underlying "ground truth" for its operation is based on the chemical principle of detecting hCG, and its performance is validated against established methods (predicate devices).

Summary

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2973858

SUMMARY OF SAFETY AND EFFECTIVENESS XI.

NOV 26 1997

Product:

CARDS® Q.S.® hCG Serum / Urine; or Concise® Performance Plus™ hCG-Combo

Distributor:

Pacific Biotech, Incorporated a subsidiary of QUIDEL Corporation 10165 McKellar Court San Diego, CA 92121 U.S.A.

Device Classification:

Intended Use:

The test is a rapid and sensitive immunoassay for the qualitative detection of hCG in serum or urine. This test is intended for use as an aid in the diagnosis of early pregnancy.

Physiologic Basis for the Assay:

Human chorionic gonadotropin (hCG) is a glycoprotein hormone secreted by the trophoblastic cells of the developing placenta as early as 7 to 8 days after ovulation. This hormone stimulates the production of progesterone and estradiol which are required to sustain pregnancy. In normal pregnancy, serum levels of hCG continue to rise during the first trimester to levels as high as 100,000 mIU/mL. Serum hCG is rapidly cleared in the urine and the concentration of hCG in serum is approximately equal to the concentration in urine. HCG is an excellent indicator of pregnancy early in the gestational period.

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Principle of the Test:

Serum or urine is added to the Reaction Unit. If hCG is present in the sample, a pink vertical line forms in the Read Result Window. This pink line, together with the pre-printed blue horizontal line, form a plus sign (+) to indicate a positive result. If hCG is not present in the sample, the Read Result Window shows only the pre-printed blue horizontal line, forming a minus sign (-) to indicate negative result.

Safety and Effectiveness:

Numerous studies were undertaken to document the performance characteristics and the substantial equivalence of the test to other commercially available products for the qualitative detection of hCG in serum or urine. These studies included the following:

· The test was shown to be similar to other commercially distributed in vitro tests in terms of features and intended use.
· The test was shown to have excellent intra- and inter-assay precision.
· Lot-to-lot consistency analyses showed the test to be reproducibly manufacturable.
· Common drugs, chemicals, and biologicals were shown not to interfere with the test's performance.
· Using samples obtained from women presenting for pregnancy testing, a direct comparison of the test to another FDA-cleared device for qualitative hCG detection was conducted. An accuracy exceeding 99% was observed.
· Physician's Office Laboratory studies were conducted to show that doctor's office personnel with diverse educational backgrounds and work experience could perform the test accurately and reproducibly. Testing was performed at three geographically distinct sites in the United States. The results obtained at each site agreed greater than 100% with the expected results.

Conclusion:

These studies demonstrated the substantial equivalence of the test to existing products already marketed. They further demonstrated the suitability of the product for use by health care professionals. Such studies are a critical element in establishing the fundamental safety and effectiveness of the product and its appropriateness for commercial distribution.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized representation of a human figure embracing another. The symbol is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the symbol. The text is in all caps and is evenly spaced around the circle.

NOV 26 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Robin Weiner . Vice President, Clinical Develop. & Reg. Affairs OUIDEL Corporation 10165 Mc Kellar Court 92121 San Diego, California

Re : K973858 CARDS® Q.S.® hCG-Serum/Urine; Concise® Performance Plus™ hCG-Combo Requlatory Class: II Product Code: JHI Dated: October 7, 1997 Received: October 9, 1997

Dear Ms. Weiner:

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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ರಿ 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 In addition, FDA may publish further announcements action. 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 requlation (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 Other general premarket notification" (21 CFR 807.97). 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/dsmamain.html".

Sincerely yours,
Steven Bitman

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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510(k) Number (if known):

9738558

CARDS® Q.S.® hCG Serum/Urine; and Concise® Performance. Plus™ hCG-Combo

Device. Name:

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. 973858

Prescription Use (Per 21 CFR 801.109)

Over-The Counter Use_

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.1155 Human chorionic gonadotropin (HCG) test system.

(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.