(47 days)
No
The device description details a traditional lateral flow immunoassay based on antibody reactions and visual interpretation of colored lines. There is no mention of any computational analysis, algorithms, or learning processes.
No
This device is a diagnostic tool used to determine pregnancy by detecting hCG; it does not provide any treatment or therapy.
Yes
The intended use explicitly states, "The ACON Quik-Check II Home Pregnancy Test Device is for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy." This indicates that the device is used to detect a biological marker (hCG) to determine a medical condition (pregnancy), which is 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 visible lines, indicating a positive or negative result. This is a hardware-based diagnostic test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy." This is a diagnostic purpose performed on a biological sample (urine).
- Device Description: The description details how the test works by reacting with components in the urine sample to detect hCG. This is the core function of an in vitro diagnostic test.
- Sample Type: It uses a urine sample, which is a biological specimen.
- Purpose: The purpose is to aid in the determination of pregnancy, which is a medical condition.
The fact that it's intended for "non-professional, over-the-counter use" doesn't change its classification as an IVD. IVDs can be designed for various user types and settings.
N/A
Intended Use / Indications for Use
The ACON Quik-Check II Home Pregnancy Test Device is for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy. It is intended for non-professional, over-the-counter use.
The ACON Quik-Check II Home Pregnancy Test Device is intended for non-professional, over-the-counter use for the qualitative identification the elevated level of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy.
Product codes
LCX
Device Description
The test utilizes a combination of mouse monoclonal and goat polyclonal antibody in conjunction with a Strepavidin-Biotin ligand-binding system to qualitatively detect elevated levels of hCC in urine sample. The assay is conducted by using a dropper to transfer three drops of urine from a urine sample that has been collected in a cup, or clean, dry container 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 Home Pregnancy Test Device 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 uIU/ml) to negative (0 mIU/ml hCG) and positive (25 mIU/ml hCG) urine showed no cross-reactivity.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical studies were conducted to compare the results of ACON Quik-Check II Home Pregnancy Test Device to the current ACON QUIK-CHECK Home Pregnancy Test Device (K012215). The consumer field study included 113 female participants and demonstrated an accuracy of over 99% correlation between the two 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 hCG tests. The results also showed that the vast majority of the participants found ACON Quik-Check II Home Pregnancy Test Device 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 Home Pregnancy Test Device is robust and will give accurate results under many adverse conditions. The should be suited for OTC use.
The overall performance data indicate that ACON Quik-Check II Home Pregnancy Test Device is safe, effective and substantially equivalent to ACON QUIK-CHECK Home Pregnancy Test Device (K012215) currently on the U. S. OTC market.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
NOV 1 4 2003
III. 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the regulation of SMDA 1990 and 21 CFR 807.92"
"The assigned 510(k) number is Ko32661
Device Names:
ACON Quik-Check II Home Pregnancy Test Device
Common Name:
Pregnancy Test Kit, Over-the-Counter
Classification Name:
Gonadotropin
Name of the Predicate Device
ACON Home Pregnancy Test Device (K012215)
Medical Specialty:
Clinical Chemistry
Device Description:
The test utilizes a combination of mouse monoclonal and goat polyclonal antibody in conjunction with a Strepavidin-Biotin ligand-binding system to qualitatively detect elevated levels of hCC in urine sample. The assay is conducted by using a dropper to transfer three drops of urine from a urine sample that has been collected in a cup, or clean, dry container 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 Home Pregnancy Test Device 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 uIU/ml) to negative (0 mIU/ml hCG) and positive (25 mIU/ml hCG) urine showed no cross-reactivity.
Intended Use:
The ACON Quik-Check II Home Pregnancy Test Device is for the qualitative detection 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 Home Pregnancy Test Device to the current ACON QUIK-CHECK Home Pregnancy Test Device (K012215). The consumer field study included 113 female participants and demonstrated an accuracy of over 99% correlation between the two 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 hCG tests. The results also showed that the vast majority of the participants found ACON Quik-Check II Home Pregnancy Test Device very easy to use, and that they had no trouble understanding the labeling, reading the instructions, or interpreting the results.
Additional Laboratory Studies 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 Home Pregnancy Test Device is robust and will give accurate results under many adverse conditions. The should be suited for OTC use.
The overall performance data indicate that ACON Quik-Check II Home Pregnancy Test Device is safe, effective and substantially equivalent to ACON QUIK-CHECK Home Pregnancy Test Device (K012215) currently on the U. S. OTC market.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of a human figure embracing a bird, which is a common symbol associated with health and human services.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 1 4 2003
Edmund Tung, Ph.D. Regulatory Affairs ACON Laboratories, Inc. 4108 Sorrento Valley Blvd. San Diego, CA 92121
Re: K032661
Trade/Device Name: ACON Quik-Check II Home Pregnancy Test Device Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: August 27, 2003 Received: August 28, 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. Ilsting 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).
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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 Butman
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
V. Indications For Use
510(k) Number: K032-60
Device Name: ACON Quik-Check II Home Pregnancy Test Device
- The ACON Quik-Check II Home Pregnancy Test Device is intended for "Indications for Use": non-professional, over-the counter use for the qualitative identification the elevated level of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy.
Carol C. Benson /s Jean Cooper, DVM
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 03.2661
or
(Please do not write below this point)
Concurrence of CDRH, Office of the In vitro Diagnostic Device Evaluation and Safety
Prescription Use______________________________________________________________________________________________________________________________________________________________
Over-The-Counter Use
(per 21 CFR 801.109)