(79 days)
Not Found
Not Found
No
The device description details a lateral flow immunoassay with a visual indicator (dye pad) for interpreting results. There is no mention of computational analysis, algorithms, or learning processes.
No
The device is a qualitative diagnostic test for pregnancy, not a therapeutic device. It aids in the early detection of pregnancy but does not treat or cure any condition.
Yes
The device qualitatively detects human Chorionic Gonadotropin (hCG) in urine to aid in the early detection of pregnancy, which is a diagnostic purpose.
No
The device description clearly describes a physical, immunochemical lateral flow immunoassay test strip, which is a hardware component, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine to aid in the early detection of pregnancy." This involves testing a sample (urine) taken from the human body in vitro (outside the body) to provide information about a physiological state (pregnancy).
- Device Description: The description details an "immunochemical formulation" and a "lateral flow immunoassay for the detection of hCG." These are common techniques used in IVD devices to analyze biological samples.
- Sample Type: The device uses a "urine sample," which is a biological specimen.
The fact that it's for "over-the-counter use" and is a "Pregnancy Test" further reinforces its classification as an IVD, as these are typical characteristics of many IVD devices available to consumers.
N/A
Intended Use / Indications for 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.
Product codes
LCX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
over-the-counter use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
95% confidence interval of 97.9-99.9%
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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.
2
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).
3
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
4
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.
Page 1 of ___1