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

Device Description

The test, a sandwich-format, lateral-flow immunoassay, employs monoclonal and polyclonal antibodies. Shortly after addition of the urine sample, a blue procedural Control Line will appear. If hCG is present in the sample, a pinkto-purple Test Line intersecting the pre-printed horizontal blue line will also appear. The result is read at three minutes after sample application. If no blue procedural Control Line develops, the result is considered invalid.

AI/ML Overview

The provided text describes the CARDS® Q.S.® hCG-Urine (and Concise® Performance Plus™ hCG-Urine) device, its intended use, and various studies performed to demonstrate its safety and effectiveness. However, it does not explicitly state formal acceptance criteria with specific numerical thresholds (e.g., sensitivity, specificity values) in a table format, nor does it present a detailed study rigorously "proving" these criteria were met with reported actual performance values in such a table.

Instead, the documentation broadly discusses studies that support the device's substantial equivalence to other FDA-cleared devices and its suitability for use.

Based on the provided text, here's an attempt to structure the information according to your requested format, while highlighting what is not explicitly stated in the document:

Acceptance Criteria and Device Performance

The provided summary does not explicitly list predefined quantitative acceptance criteria in a table format with corresponding reported performance values. It discusses various studies that demonstrated the device's performance characteristics and substantial equivalence.

Reported Performance Claims (from the "Safety and Effectiveness" section):

Performance Aspect	Reported Outcome
Accuracy (compared to other FDA-cleared qualitative hCG devices)	Exceeding 99%
Intra-assay precision	Excellent
Inter-assay precision	Excellent
Lot-to-lot consistency	Reproducibly manufacturable
Interference with common substances	Common drugs, chemicals, and biologicals were shown not to interfere with the test's performance.
Physician's Office Laboratory (POL) Accuracy	Results from three distinct sites in the United States agreed greater than 99% with expected results.

Detailed Study Information:

Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not explicitly stated. The document mentions "urine samples obtained from women presenting for pregnancy testing" and "Physician's Office Laboratory studies... at three geographically distinct sites in the United States." No specific number of samples or participants is provided.
- Data Provenance: United States (for POL studies, and implied for the comparison study as it's for FDA clearance). The data appears to be prospective in nature, as samples were "obtained from women presenting for pregnancy testing."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not explicitly stated. The document refers to "expected results" for ground truth, but does not detail how this ground truth was established (e.g., by experts, reference laboratory tests, or clinical outcomes). For POL studies, it states "doctor's office personnel with diverse educational backgrounds and work experience could perform the test accurately and reproducibly," implying that their results were compared against an 'expected result' reference.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not explicitly stated. Given the nature of a rapid immunoassay, it's unlikely that a complex adjudication method like 2+1 or 3+1 would be applicable for determining the ground truth of hCG presence in urine samples. The "expected results" likely refer to results from a recognized reference method or device.
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:
- No, an MRMC comparative effectiveness study was not performed. This device is an in-vitro diagnostic (IVD) immunoassay, not an AI-assisted diagnostic tool requiring human reader interpretation in the context of radiology or pathology images. The "Physician's Office Laboratory studies" served a similar purpose of demonstrating usability by diverse personnel, but it's not an MRMC study in the typical sense of AI comparison. The studies showed that "doctor's office personnel with diverse educational backgrounds and work experience could perform the test accurately and reproducibly."
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The device itself is a standalone immunoassay; its "performance" is its ability to detect hCG in a sample. The "Accuracy exceeding 99%" study refers to the device's intrinsic performance against other established qualitative hCG detection devices. The Physician's Office Laboratory studies evaluate usability and reproducibility rather than standalone algorithmic performance in the modern AI sense.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not explicitly stated. For the "Accuracy exceeding 99%" study, the ground truth likely came from a comparison to "other FDA-cleared devices for qualitative hCG detection," meaning the results of these established devices served as the reference standard. For the POL studies, it was against "expected results," which would similarly be derived from a reference method. It's improbable that pathology or long-term outcomes data would be used as ground truth for a qualitative hCG urine test.
The sample size for the training set:
- This concept is not applicable as the device is a chemical immunoassay, not a machine learning or AI model that requires a "training set" in the computational sense. Its performance is inherent in its biochemical design and manufacturing consistency.
How the ground truth for the training set was established:
- Not applicable for the same reasons as #7.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS

Product:

AUG 29 1991

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

Distributor:

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

Device Classification:

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

Intended Use:

The test is a rapid immunoassay for the qualitative detection of hCG in urine. This test is to be used for the early detection of 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:

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 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 urine samples obtained from women presenting for pregnancy testing, a direct comparison of the test to other FDA-cleared devices 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 99% 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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AUG 2 9 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 San Diego, California 92121

K972748 Re : CARDS® Q.S.® hCG-Urine; Concise® Performance Plus™ hCG-Urine Regulatory Class: II Product Code: JHI Dated: July 22, 1997 Received: July 23, 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. 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 requlation (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 requlations.

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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 assorizoof 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 diaqnostic 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/dsmamain.html".

Sincerely yours,
Steven Litman

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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Page __ 1 _ of _______________________________________________________________________________________________________________________________________________________________

ਹੈ। ਹ

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

CARDS® Q.S.® hCG-Urine Concise® Performance Plus™ hCG-Urine

Indications for Use:

The CARDS® Q.S.® hCG-Urine (also sold under the brand name The CARDSO Qlonce Plus™ hCG-Urine) is a one-step immunoassay Concises for the qualitative detection of human chorionic Intended - 101 - and of the early detection of pregnancy. The test is intended for use by health care professionals.

(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
59472748

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.