An OTC hCG Pregnancy Test for home use intended for the early detection of pregnancy. It is intended to measure hCG, a placental hormone, in urine sample.

Device Description

The Sure Check™ Pregnancy Test is a self contained immunochromatographic test designed for use in detecting hCG in urine samples. After the person wets the wick in the device the urine is absorbed and transferred to a pad where a labelled colloidal gold containing a monoclonal antibody directed against beta hCG is present. If the antigen (hCG) is present, an antigen/antibody reaction takes place forming a complex. This migrates along the nitrocellulose support to the Test Line which is printed on the membrane. This is another antibody, in this case a monoclonal anti-hCG antibody, which captures the colored complex when it passes over the immobilized test line antibody. As the complex adheres to the capture antibody a visible light to dark purple band appears indicating a positive test result. The remaining complex travels further along the membrane to another immobilized control antibody. This captures the remaining complex forming another purple band indicating that the test has been performed properly.

AI/ML Overview

{
  "acceptance_criteria_and_performance_table": {
    "title": "Sure Check™ Pregnancy Test Performance vs. Predicate Device (Chembio HCG STAT-PAK)",
    "headers": ["Metric", "Acceptance Criteria", "Reported Sure Check™ Performance"],
    "rows": [
      ["Early Detection of Pregnancy", "Not explicitly stated, but implied to be comparable to predicate", "Effective in diagnosing pregnancy"],
      ["Accuracy (vs. Predicate Device)", "Comparable to predicate device", "Demonstrated substantial equivalence"],
      ["Sensitivity/Detection Limit", "Not explicitly stated, but implied to be acceptable", "Testing conducted (Exhibit #6a)"],
      ["Specificity", "Not explicitly stated, but implied to be acceptable", "Testing conducted (Exhibit #7b)"],
      ["Interfering Substances", "Not explicitly stated, but implied to be acceptable", "Testing conducted (Exhibit #8c)"],
      ["Time Study for Holding Device in Urine Stream", "Not explicitly stated, but implied to be acceptable", "Testing conducted (Exhibit #9d)"],
      ["Optimal Reaction Time", "Not explicitly stated, but implied to be acceptable", "Testing conducted (Exhibit #10e)"],
      ["Reproducibility", "Not explicitly stated, but implied to be acceptable", "Testing conducted (Exhibit #11f)"],
      ["Linearity", "Not explicitly stated, but implied to be acceptable", "Testing conducted (Exhibit #12g)"]
    ]
  },
  "sample_size_test_set": "Not specified in the provided text. The document refers to \"clinical trials\" and \"Comparative Study Data\" (Exhibit #3) but does not provide the exact sample size.",
  "data_provenance": "The clinical trials were conducted by Target Health Inc. in New York, NY. The data appears to be prospective, collected for the purpose of the study (an \"Open Study to Evaluate the Ability of Sure Check™ to Determine Pregnancy\"). The country of origin for the data is the USA.",
  "number_of_experts_ground_truth_test_set": "Not specified. The ground truth for the clinical trials was established by comparison to a \"currently marketed device (Professional Use)\", the Chembio HCG STAT-PAK, K#923925/A. It's not explicitly stated that experts established the ground truth for individual cases, but rather a professional-use device served as the reference standard.",
  "qualifications_experts_ground_truth_test_set": "Not applicable, as expert involvement in establishing ground truth for individual cases is not specified. The reference standard was a professional-use device.",
  "adjudication_method_test_set": "Not applicable/Not specified. The study compared the Sure Check™ to a predicate device; it doesn't mention a specific adjudication method for discrepancies between test results and a true ground truth if that ground truth itself was established by human readers.",
  "mrmc_comparative_effectiveness_study": "No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study compares the new device (Sure Check™) to a predicate device (Chembio HCG STAT-PAK) in clinical trials for accuracy. It's a device-to-device comparison, not an evaluation of human readers' improvement with or without AI assistance.",
  "standalone_performance_done": "Yes, a standalone performance study was done for the device. The clinical trials evaluate the device's accuracy in diagnosing pregnancy. The non-clinical tests (Sensitivity/Detection Limit, Specificity, etc.) also assess the device's inherent performance characteristics.",
  "type_of_ground_truth_used": "The ground truth for the clinical trials was established by correlation with a currently marketed professional-use device, the Chembio HCG STAT-PAK. This implies that the results of the predicate device were considered the reference standard for truth in diagnosing pregnancy.",
  "sample_size_training_set": "Not applicable. This device is an immunochromatographic test, not an AI/ML algorithm that requires a training set in the conventional sense.",
  "how_ground_truth_training_set_established": "Not applicable, as this device does not use an AI/ML algorithm that requires a training set with established ground truth."
}

Summary

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EXHIBIT #1 Page 1 of 3

K96/965

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 9807.92.

The assigned 510(k) number is:

1. Submitter's Identification:

Mr. Paul Reiter Chief Operating Officer Chembio Diagnostic Systems, Inc. 3661 Horseblock Road Medford, NY 11763

Date Summary Prepared: May 14, 1996

2. Name of the Device:

Sure Check™ Pregnancy Test

3. Predicate Device Information:

Chembio HCG STAT-PAK, K#923925/A Clearblue Easy Pregnancy Test, E.P.T. Pregnancy Test

4. Device Description:

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5. Intended Use:

An OTC hCG Pregnancy Test for home use intended for the early detection of pregnancy. It is intended to measure hCG, a placental hormone, in urine sample.

6. Comparison to Predicate Devices:

The Sure Check™ Pregnancy Test was compared in clinical trials to the Chembio HCG STAT-PAK, K#923925/A.

The Sure Check™ Pregnancy Test is designed as a home use midstream test where the sample is added via urinating directly onto an absorbent wick. The sample is transferred to the reactive membrane via this membrane where the reactions take place as described above. The HCG STAT-PAK utilizes the same immunochromatographic principle as described in Section 4-Device Description with the exception that the sample is collected in a cup/container and added via a dropper supplied with the kit. However, aside from the method in which the sample is added to the membrane, there are no differences in the chemistry between the tests.

7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Testing information demonstrating safety and effectiveness of the Sure Check™ Pregnancy Test in the intended environment of use is supported by testing that was conducted in accordance with the FDA's Clinical Chemistry's "Draft-Review Criteria for Assessment of Human Chorionic Gonadotropin (hCG) In Vitro Diagnostic Devices (IVDs), " 9/27/95.

The following testing was conducted by Chembio Diagnostic Systems, Inc. personnel:

Sensitivity/Detection Limit Study Exhibit #6 a.
Specificity Study Exhibit #7 b.
Interfering Substance Study Exhibit #8 C.
Time Study For Holding the Device in the Urine Stream Exhibit #9 d.
Optimal Reaction Time Study Exhibit #10 0.
f. Reproducibility Study - Exhibit #11
Linearity Study Exhibit #12 0

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None of the testing demonstrated any design characteristics that deviated from the requirements of the Reviewer Guidance or resulted in any safety or effectiveness concerns.

Discussion of Clinical Tests Performed: 8.

The Sure Check® Pregnancy Test was compared in clinical trials to the Chembio HCG STAT-PAK. Please refer to Exhibit #3. "Comparative Study Data: Accuracy as Determined by Correlation of Proposed Device with Currently Marketed Device (Professional Use)" - "Clinical Trial Report: An Open Study to Evaluate the Ability of Sure Check™ to Determine Pregnancy" - Study Conducted and Monitored by: Target Health Inc., 310 Madison Avenue, 22nd Floor, New York, NY 10017, concluding that our device is effective in diagnosing pregnancy.

9. Conclusions:

Our testing demonstrated that the Sure Check™ Pregnancy Test is as safe and effective as the predicate device for the intended use of the device.

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.