(39 days)
No
The device description details a qualitative immunoassay based on antibody reactions and visual interpretation of colored lines, with no mention of computational analysis or learning algorithms.
No.
The device is a diagnostic tool for detecting pregnancy, not a device used for therapy or treatment.
Yes
The device is described as a "qualitative test for the detection of the elevated level of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy," which directly aligns with the definition of a diagnostic device.
No
The device description clearly outlines a physical test strip that utilizes chemical reactions and capillary action to produce a visual result. There is no mention of any software component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "qualitative test for the detection the elevated level of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy." This describes a test performed in vitro (outside the body) on a biological sample (urine) to provide diagnostic information (pregnancy).
- Device Description: The description details the use of antibodies and a ligand-binding system to detect hCG in a urine sample. This is a typical mechanism for an in vitro diagnostic assay.
- Sample Type: The test uses urine, which is a biological specimen.
- Purpose: The purpose is to "aid in the determination of pregnancy," which is a diagnostic purpose.
The fact that it's intended for "non-professional, over-the counter use" doesn't change its classification as an IVD. IVDs can be intended for use by healthcare professionals or lay users.
N/A
Intended Use / Indications for Use
The ACON Quik-Check II Midstream Home Pregnancy Test is a qualitative test for the detection the elevated level of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy. It is intended for non-professional, over-the counter use.
Product codes
LCX
Device Description
The test utilizes a combination of mouse monoclonal and goat polyclonal antibody in conjunction with a proprietary strepavidin-biotin ligand-binding system to qualitatively detect elevated levels of hCG in urine sample. The assay is conducted by applying urine sample through urination, or dipping test device into collected urine sample, and observing for the formation of colored lines. The specimen migrates via capillary action along the components of the test device to react with the colored conjugate. During migration, hCG molecules in the positive urine sample react with the hCG-specific antibodies, which were conjugated with colored particles, and form a colored line on the "Test Region" of the membrane. A colored line forms in the test (T) region indicates a positive result; while absence of this colored line indicates a negative result. To serve as a procedural control, a colored line at the control (C) region will always appear, indicating adequate sample volume and proper wicking, regardless of the presence of hCG. Absence of this control line in the C region indicates that the test result is "invalid". The ACON Quik-Check II Midstream Home Pregnancy Test qualitatively detects hCG in urine with a designated cutoff hCG concentration of 25 mIU/ml. This test has been standardized to the World Health Organization Third International Standard. The addition of hLH (300 mIU/ml), hFSH (1,000 mIU/ml), and hTSH (1,000 IU/ml) to negative (0 mIU/ml hCG) and positive (25 mIU/ml hCG) urine showed no crossreactivity.
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
non-professional, 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
Clinical studies were conducted to compare the results of ACON Quik-Check II Midstream home Pregnancy Test to the current ACON Midstream Pregnancy Test (K983090). The consumer field study included 113 female participants and demonstrated an accuracy of over 99% correlation between the two midstream hCG tests. The retrospective focus group study on reproducibility and precision included 35 female participants and demonstrated an accuracy of over 99% correlation between the two midstream hCG tests.
Summary of Performance Studies
Clinical studies were conducted to compare the results of ACON Quik-Check II Midstream home Pregnancy Test to the current ACON Midstream Pregnancy Test (K983090). The consumer field study included 113 female participants and demonstrated an accuracy of over 99% correlation between the two midstream hCG tests. The retrospective focus group study on reproducibility and precision included 35 female participants and demonstrated an accuracy of over 99% correlation between the two midstream hCG tests. The results also showed that the vast majority of the participants found ACON Ouik-Check II Midstream Home Pregnancy Test very easy to use, and that they had no trouble understanding the labeling, reading the instructions, or interpreting the results. Additional laboratory study results on performance include specificity, interference substances, urinary pH, urinary specific gravity, and does hook effect. These results indicate that the ACON Quik-Check II Midstream Home Pregnancy Test is robust and will give accurate results under many adverse conditions. The overall performance data indicate that ACON Quik-Check II Midstream Home Pregnancy Test (Home Tests) is safe, effective and substantially equivalent to ACON Home Pregnancy Test (K983090) currently on the U. S. OTC market.
Key Metrics
accuracy of over 99% correlation
Predicate Device(s)
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
III. 510(k) Summary
This summary of 510(k) safety and effective ness information is being submitted in accordance with the regulation of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is K032510.
Device Names:
ACON Quik-Check II Midstream Home Pregnancy Test
Common Name:
Pregnancy Test Kit, Over-the-Counter
Classification Name:
Gonadotropin
Name of the Predicate Device
ACON Midstream Home Pregnancy Test (K983090)
Medical Specialty:
Clinical Chemistry
Device Description:
The test utilizes a combination of mouse monoclonal and goat polyclonal antibody in conjunction with a proprietary strepavidin-biotin ligand-binding system to qualitatively detect elevated levels of hCG in urine sample. The assay is conducted by applying urine sample through urination, or dipping test device into collected urine sample, and observing for the formation of colored lines. The specimen migrates via capillary action along the components of the test device to react with the colored conjugate. During migration, hCG molecules in the positive urine sample react with the hCG-specific antibodies, which were conjugated with colored particles, and form a colored line on the "Test Region" of the membrane.
1
A colored line forms in the test (T) region indicates a positive result; while absence of this colored line indicates a negative result. To serve as a procedural control, a colored line at the control (C) region will always appear, indicating adequate sample volume and proper wicking, regardless of the presence of hCG. Absence of this control line in the C region indicates that the test result is "invalid".
The ACON Quik-Check II Midstream Home Pregnancy Test qualitatively detects hCG in urine with a designated cutoff hCG concentration of 25 mIU/ml. This test has been standardized to the World Health Organization Third International Standard. The addition of hLH (300 mIU/ml), hFSH (1,000 mIU/ml), and hTSH (1,000 IU/ml) to negative (0 mIU/ml hCG) and positive (25 mIU/ml hCG) urine showed no crossreactivity.
Intended Use:
The ACON Quik-Check II Midstream Home Pregnancy Test is a qualitative test for the detection the elevated level of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy. It is intended for non-professional, over-the counter use.
Clinical Studies:
Clinical studies were conducted to compare the results of ACON Quik-Check II Midstream home Pregnancy Test to the current ACON Midstream Pregnancy Test (K983090). The consumer field study included 113 female participants and demonstrated an accuracy of over 99% correlation between the two midstream hCG tests. The retrospective focus group study on reproducibility and precision included 35 female participants and demonstrated an accuracy of over 99% correlation between the two midstream hCG tests. The results also showed that the vast majority of the participants found ACON Ouik-Check II Midstream Home Pregnancy Test very easy to use, and that they had no trouble understanding the labeling, reading the instructions, or interpreting the results.
Additional Study to Establish Substantial Equivalence:
Additional laboratory study results on performance include specificity, interference substances, urinary pH, urinary specific gravity, and does hook effect. These results indicate that the ACON Quik-Check II Midstream Home Pregnancy Test is robust and will give accurate results under many adverse conditions.
The overall performance data indicate that ACON Quik-Check II Midstream Home Pregnancy Test (Home Tests) is safe, effective and substantially equivalent to ACON Home Pregnancy Test (K983090) currently on the U. S. OTC market.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image is a black and white circular logo. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circle. Inside the circle is a symbol that resembles a stylized eagle or bird in flight, composed of three curved lines.
SEP 2 2 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Edward Tung, Ph.D. Regulatory Affairs ACON Laboratories, Inc. 4108 Sorrento Valley Blvd San Diego, CA 92121
Re: K032510
Trade/Device Name: ACON Quik-Check II Mainstream Home Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: September 5, 2003 Received: September 11, 2003
Dear Dr. Tung:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality 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) premarket notification. The FDA finding of 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications For Use V.
510(k) Number: K032510
Device Name: ACON Quik-Check II Midstream Home Pregnancy Test
- The ACON Quik-Check II Midstream Home Pregnancy Test is a "Indications for Use": qualitative test for the detection of the elevated levels of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy. It is intended for non-professional, over-the counter use.
Division Sign-Of
Office of In Vitro Diagnostic Device Evaluation and Safety
KO32510 510(k).
(Please do not write below this point)
Concurrence of CDRH, Office of the In vitro Diagnostic Device Evaluation and Safety
or
Prescription Use______________________________________________________________________________________________________________________________________________________________
Over-The-Counter Use
(per 21 CFR 801.109)