(79 days)
The ACON +/- Midstream Pregnancy Test is for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine to aid in the early detection of pregnancy. It is for over-the-counter use.
ACON +/- Midstream Pregnancy Test is a modified device from the previously FDA-cleared ACON ACON +/- Mustleann Fregnancy Test is a The immunochemical formulation, which employs an Midsleam Tregnancy Color particle sandwich binding, lateral flow immunoassay for the detection of hCG, remains the same for the modified device. With the incorporation of a proprietary moisture-sensitive dye pad within the test strip, an additional test line perpendicular to the regulation thoisture-sellsitive dyc pac willin the test bevice. The moisture-sensitive dye pack to treasur the test the will develop for the mounted test connect by urine sample. Regardless of the test result, this change from coloness to pinnered color with the user. While the un-modified device will have a colored test line developed in the result window for positive result and no colored line for negative colored test inte developed in the result willion to press. "+" pattern in the result window for positive result, and a colored "-" pattern for negative result.
ACON +/- Midstream Pregnancy Test
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Ability of laypersons to correctly read and interpret test results | >99% accuracy (259/260 with 95% confidence interval of 97.9-99.9%) |
2. Sample size used for the test set and the data provenance
- Sample size: 260 participants (referred to as "lay persons"). The origin of the participants (country) is not specified.
- Data provenance: Prospective, as it involved participants actively using and interpreting the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the layperson readability study. However, the study focuses on the layperson's ability to interpret predefined "positive" or "negative" signs (+ or -) on the test, rather than a clinical diagnosis. The ground truth for individual test results would likely have been established by performing the test and observing the expected chemical reaction (presence or absence of hCG) against a known standard.
4. Adjudication method for the test set
The document does not describe an explicit adjudication method for the layperson readability study. The study's focus was on the participants' interpretation of the displayed result, implying that each participant's interpretation was compared against the intended (correct) interpretation for that specific test result.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a rapid diagnostic test, not an AI-powered diagnostic tool requiring human-in-the-loop assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable, as the device is not an algorithm or AI. The "standalone" performance here refers to the device's ability to qualitatively detect hCG at a specific cutoff concentration, which is stated to be 25 mIU/mL. The document also states that urine samples with 0 mIU/mL hCG (negative) and 25 mIU/mL hCG (positive) did not interfere with correct reading.
7. The type of ground truth used
For the layperson readability study, the ground truth was the intended visual interpretation of the test result patterns ("+" for positive, "-" for negative).
For the device's analytical performance (hCG detection), the ground truth for establishing sensitivity was against World Health Organization Fourth International Standard for Chorionic Gonadotropin.
8. The sample size for the training set
The document does not mention a "training set" as this is not an AI/machine learning device. The clinical study described is a readability study, which serves as a validation of the device's ease of use for its intended over-the-counter user.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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MAY 2 0 2005
510(k) Summary
Device Names:
ACON +/- Midstream Pregnancy Test
Common Name:
Pregnancy Test Kit, Over-the-Counter
Classification Number:
862.1155
FDA Product Code:
LCX
Medical Specialty:
Clinical Chemistry
Intended Use:
The ACON +/- Midstream Pregnancy Test is for the qualitative detection of human Chorionic The ACON 17- Midstrain Programs) - Fees to to to to to to to to of pregnancy. It is for over-the-counter use.
Device Description:
ACON +/- Midstream Pregnancy Test is a modified device from the previously FDA-cleared ACON ACON +/- Mustleann Fregnancy Test is a The immunochemical formulation, which employs an Midsleam Tregnancy Color particle sandwich binding, lateral flow immunoassay for the detection of hCG, remains the same for the modified device. With the incorporation of a proprietary moisture-sensitive dye pad within the test strip, an additional test line perpendicular to the regulation thoisture-sellsitive dyc pac willin the test bevice. The moisture-sensitive dye pack to treasur the test the will develop for the mounted test connect by urine sample. Regardless of the test result, this change from coloness to pinnered color with the user. While the un-modified device will have a colored test line developed in the result window for positive result and no colored line for negative colored test inte developed in the result willion to press. "+" pattern in the result window for positive result, and a colored "-" pattern for negative result.
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Therefore, a colored "+" sign forms in the result window indicates a possive ers a presedured I nerelore, a colored - - sign in the result window indicates a negative result. To serve as a procedural presence of a - - sigli in the result window indicating adequate sample volume and control, a red inte will always appeal in the control winessample. The absence of the redition proper wicking, regardless or the presence or the mind is "invalid". For the modified cost result avon control mic of a horizontal line in the result window also constitutes an "invalid" test result even there is a red line present in the control window.
The ACON +/- Midstream Pregnancy Test qualitatively detects hCG in urine sample with a The ACON 7/- Midstrom Pregnancy - C mIU/mL. The cutoff concentration of this test has been designated colloir the World Health Organization Fourth International Standard for Chorionic Standardized to the World Treath Organized of LH (300 mIU/mL), FSH (1,000 mU/mL), or Ochadouvpll (NHDSC Code: 1970271 ve (0 mIUmL hCG) or positive (25 mIU/mL hCG) urine samples did not interfere in correctly reading of the expected test result.
Clinical Study:
A device readability study using the ACON +/- Midstream Pregnancy Test by participants with no A device readability study assilg the 1 Occuracy of over 99% (2.59/260 with 95% confidence interval of 97.9-99.9%), indicating that the vast majority of lay persons are able to correctly read and interpret the test results following the package insert's instructions.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 2 0 2005
Edward Tung, Ph.D. Regulatory Affairs ACON Laboratories Inc. 4108 Sorrento Valley Blvd San Diego, CA 92121
K050546 Re:
R050540
Trade/Device Name: ACON +/- Midstream Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: May 2, 2005 Received: May 3, 2005
Dear Dr. Tung:
We have reviewed your Section 510(k) premarket notification of intent to market the indication we have reviewed your Section 910(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regard manatist date of the Medical Device Advanced Ford Deva commerce provision of May 20, 1976, the enated with the provisions of the Federal Food. Drug, devices that have been reclassified in acceraaned what a premarket approval application (PMA). allo Cosmenc Act (Act) that do not require to the general controls provisions of the Act. The You may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the fice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (500 a00 v) arols. Existing major regulations affecting your device and diving and this a It may be subject to such additional controllations (CFR), Parts 800 to 895. In addition, FDA can oc louid in This 21, Cour Crice oncerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issuation of a backers. In the requirements of the Act
that FDA has made a determination that your device complies with other requirements of th that I DA has made a decornmancing administered by other Federal agencies. You must of any Federal Statules and regulations daminities. or registration and listing (21 comply with an the Ace 31equirements 801 and 809); and good manufacturing practice to CFR Fall 607), labeling (21 CF ruality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will allow you to ocgin makemig your antial equivalence of your device to a legally premarket notification. The PDA miding of Subscances quarterice and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, of In If you desire specific information acourt is appear device, please contact the Office of In
or questions on the promotion and advertising of your and advertising of the or questions on the promotion and acreening commitments on your consection of (240) 276-0484 Vitro Diagnostic Device Livanianon and Barey and (210). (210FR Part 807.97).
regulation entitled, "Misbranding by reference to premarket notification Ast from the You may obtain other general information on your responsibilities under the Act from the You may of all other general information on Jour responser Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Carol C. Benam
Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications For Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ACON +/- Midstream Pregnancy Test
- The ACON +/- Midstream Pregnancy Test is intended for over-the-counter "Indications for Use": use for the qualitative identification of the elevated level of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Rutea Chulen
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number.
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§ 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.