(37 days)
The QUIK-CHECK™ Ovulation Predictor Test is a qualitative, one-step, midstream assay for the detection of human Luteinizing Hormone (LH) in urine as an aid in conception by reliably predicting ovulation. The QUIK-CHECK™ Ovulation Predictor Test is intended for use by the lay consumer.
The QUIK-CHECK™ Ovulation Predictor Test is a midstream test used for the qualitative measurement of Luteinizing Hormone (LH) and the detection of the LH surge in a woman's urine as an aid in reliably predicting ovulation. The ovulation predictor test is intended for use outside the body (in vitro diagnostic use) by women at home. The QUIK-CHECK™ ass outside the counter (OTC) device that will be sold under that will be sold under the QUIK-CHECK™ brand and various private labels. The QUIK-CHECK™ Ovulation Predictor Test employs a unique combination of monoclonal antibody-dye particle conjugates and polyclonal-solid phase antibodies to selectively identify human Luteinizing Hormone (LH) in urine. As the urine flows through the absorbent portion of the device, the antibody-dye particle conjugate binds to the LH, forming an antibodyantigen complex. This complex binds to the anti-LH antibody in the test zone and produces a pink-rose color band. The color intensity of this band is equal to or greater than that of the control band when the LH concentration is greater than 40 mIU/mL. In urine with LH concentrations of less than 40 mIU/mL, the band in the test zone will appear lighter than the control band. In the absence of LH in urine, no test band will show up in the test zone. The test has also incorporated a control system where a pink-colored band will always appear in the control zone, demonstrating that the test is functioning correctly.
Here's a breakdown of the acceptance criteria and study details for the QUIK-CHECK™ Ovulation Predictor Test, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Comparison to ClearPlan Easy®) | Reported Device Performance (QUIK-CHECK™) |
|---|---|
| Substantially equivalent to ClearPlan Easy® Ovulation Test. | Trained Lab Technician (QUIK-CHECK™ vs. ClearPlan Easy®): >99% Accuracy (99% - 100%* CI) |
| Consumer (QUIK-CHECK™ vs. ClearPlan Easy®): 95% Accuracy (94% - 96%* CI) | |
| Test functioning correctly (control band always appears). | "a pink-colored band will always appear in the control zone, demonstrating that the test is functioning correctly." (Implied acceptance met) |
| Detection of LH surge when LH concentration is greater than 40 mIU/mL (test band equal to or greater than control). | "The color intensity of this band [test band] is equal to or greater than that of the control band when the LH concentration is greater than 40 mIU/mL." |
| Test band lighter than control band when LH concentration is less than 40 mIU/mL. | "In urine with LH concentrations of less than 40 mIU/mL, the band in the test zone will appear lighter than the control band." |
| No test band in the absence of LH. | "In the absence of LH in urine, no test band will show up in the test zone." |
* Note: The document explicitly states "95% confidence Intervals" for the accuracy percentages.
Study Information
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 100 females
- Data Provenance: The study was a "clinical trial" with volunteers conducting testing at "home" and providing "urine samples." The "study coordinator tested each sample." There's no explicit mention of the country of origin, but the manufacturer and correspondent are in the US, while the manufacturing plant is in China. Given the context of a 510(k) summary for the US market, it's highly probable the clinical trial was conducted in the US. The data is prospective as it involved volunteers performing tests over a menstrual cycle.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Number of Experts: Not explicitly stated as "experts" establishing ground truth. The "study coordinator" tested each sample using both the QUIK-CHECK™ and the ClearPlan Easy® Tests. Given the context of comparing the new device to a predicate, the ClearPlan Easy® Test itself served as the reference for ground truth in this comparative study. Separately, one part of the analysis involved a "Trained Lab Technician" for both devices.
- Qualifications: "Trained Lab Technician." No specific details on their years of experience or precise qualifications (e.g., specific certifications) are provided.
4. Adjudication Method for the Test Set:
- The text describes a direct comparison: "The study coordinator tested each sample using the QUIK-CHECK™ and the ClearPlan Easy® Tests. The data obtained was recorded as Negative (no surge) or Positive (surge)." There is no mention of an adjudication method involving multiple readers resolving discrepancies. The comparison is directly between the two tests' results as interpreted by the study coordinator or consumer.
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:
- No, an MRMC comparative effectiveness study involving AI assistance for human readers was not conducted. This device is an in-vitro diagnostic test, not an AI-powered system providing assistance to human readers for image interpretation or diagnosis. The comparisons are between two similar diagnostic tests, used either by trained personnel or consumers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:
- This question is not applicable in the typical sense of AI algorithms. The device itself is a standalone diagnostic test. Its performance was evaluated both when interpreted by "Trained Lab Technician" and by the "Consumer," indicating the device's standalone performance under different user conditions.
7. The Type of Ground Truth Used:
- The ground truth in this study was established by comparative testing against a legally marketed predicate device, the ClearPlan Easy® Ovulation Test. The aim was to demonstrate "substantial equivalence" to this established product. The "data obtained was recorded as Negative (no surge) or Positive (surge)" for both devices, implying the ClearPlan Easy® result served as the de-facto ground truth for evaluating the QUIK-CHECK™ device's accuracy in identifying LH surges.
8. The Sample Size for the Training Set:
- The document describes "A clinical trial... to compare the performance." This sounds like a validation or test set rather than a training set as would be discussed for machine learning algorithms. There is no mention of a separate "training set" or a developmental phase with a distinct sample size for this device. The 100 females served as the test set for the performance evaluation.
9. How the Ground Truth for the Training Set Was Established:
- As there is no distinct "training set" mentioned in the context of this 510(k) summary for a point-of-care diagnostic device, this question is not explicitly addressed. The development of such devices typically involves internal testing and calibration, but the provided text focuses on the clinical validation study for regulatory submission.
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510(k) SUMMARY 10.
Date of Summary:
July 6, 2001
Product Name:
QUIK-CHECK™ Ovulation Predictor Test
Sponsor's Name:
ACON Laboratories, Inc. 4108 Sorrento Valley Blvd. San Diego, CA 92121 Establishment Number : 2531491
Manufactured by:
ACON Biotech (Hangzhou) Co. Ltd. 118 Tianmushan Rd. Gudang Industrial Park Hangzhou, P.R. China 310023 Owner/Operator Number: 9033096
Correspondent in the U.S .:
MDC ASSOCIATES Fran White Regulatory Consultant 163 Cabot Street Beverly, MA 01915
Substantially Equivalent Device:
Product: ClearPlan Easy® Ovulation Test Manufactured by: Unipath K Number: K981207
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PRODUCT DESCRIPTION:
The QUIK-CHECK™ Ovulation Predictor Test is a midstream test used for the qualitative measurement of Luteinizing Hormone (LH) and the detection of the LH surge in a woman's urine as an aid in reliably predicting ovulation. The ovulation predictor test is intended for use outside the body (in vitro diagnostic use) by women at home. The QUIK-CHECK™ ass outside the counter (OTC) device that will be sold under that will be sold under the QUIK-CHECK™ brand and various private labels.
INTENDED USE:
QUIK-CHECK™ Ovulation Predictor Test is a qualitative, one-step, midstream assay for the detection of human Luteinizing Hormone (LH) in urine as an aid in conception by reliably predicting ovulation. The QUIK-CHECK™ Ovulation Predictor Test is intended for use by the lay consumer.
SUMMARY OF TECHNOLOGY:
The QUIK-CHECK™ Ovulation Predictor Test employs a unique combination of monoclonal antibody-dye particle conjugates and polyclonal-solid phase antibodies to selectively identify human Luteinizing Hormone (LH) in urine. As the urine flows through the absorbent portion of the device, the antibody-dye particle conjugate binds to the LH, forming an antibodyantigen complex. This complex binds to the anti-LH antibody in the test zone and produces a pink-rose color band. The color intensity of this band is equal to or greater than that of the control band when the LH concentration is greater than 40 mIU/mL. In urine with LH concentrations of less than 40 mIU/mL, the band in the test zone will appear lighter than the control band. In the absence of LH in urine, no test band will show up in the test zone. The test has also incorporated a control system where a pink-colored band will always appear in the control zone, demonstrating that the test is functioning correctly.
PERFORMANCE DATA:
A clinical trial was done to compare the performance of the QUIK-CHECK™ Ovulation Predictor Test to a substantially equivalent product (ClearPlan Easy") manufactured by Unipath. Data clearly demonstrate that the performance of the QUIK-CHECK™ Ovulation Predictor Test is substantially equivalent to the ClearPlan Easy® Test.
QUIK-CHECK™ Ovulation Predictor Test vs. ClearPlan Easy® Ovulation Test:
100 females tested the QUIK-CHECK™ Ovulation Predictor Test to determine their respective LH surges over a period of ten consecutive days for one menstrual cycle. Each volunteer conducted the testing at home according to the package insert instructions. The urine samples were refrigerated and provided to the study coordinator. The study coordinator tested each sample using the OUIK CHECK™ and the ClearPlan Easy® Tests. The data obtained was recorded as Negative (no surge) or Positive (surge).
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Summary of Results:
| Tests (tester) | Accuracy |
|---|---|
| QUIK-CHECKTM (Trained Lab Technician) vs. ClearPlan Easy®(Trained Lab Technician) | >99%(99% - 100%*) |
| QUIK-CHECKTM (Consumer) vs. ClearPlan Easy® (Consumer) | 95%(94% - 96%*) |
| QUIK-CHECKTM (Trained Laboratory Technician) vs. QUIK-CHECKTM (Consumer) | 95%(94% - 96%*) |
- 95% confidence Intervals
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of several curved lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 1 8 2001
ACON Laboratories, Inc. c/o Ms. Fran White Regulatory Consultant 163 Cabot Street Beverly, MA 01915
Re: K012252 Trade/Device Name: QUIK-CHECK™ Ovulation Predictor Test Regulation Number: 21 CFR 862.1485 Regulatory Class: I, reserved Product Code: CEP Dated: July 6, 2001 Received: July 18, 2001
Dcar Ms. White:
This letter replaces and corrects letter dated August 24, 2001. The device name was incorrect. It was spelled Quick-Check. It should be spelled Quik-Check.
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 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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 regulations.
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Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) premarket I mis letter will and by your ding of substantial equivalence of your device to a legally marketed noalicate 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 mornation on Jour Port Post Stance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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: Device Name: QUIK-CHECK™ Ovulation Predictor Test
Indication for Use:
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predicting ovulation. The QUIK-CHECK™ Ovulation Predictor Test is intended for use by the lay consumer.
(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 (Optional Format 1-2-96)
Kesia Alexander for Ivan Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K012252
§ 862.1485 Luteinizing hormone test system.
(a)
Identification. A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.