(60 days)
Not Found
No
The summary describes a standard in vitro diagnostic test for pregnancy based on qualitative detection of hCG, with no mention of AI, ML, image processing, or any computational analysis beyond a visual interpretation.
No
The device is described as an "In Vitro diagnostic test for the qualitative detection of hCG in human urine to aid in the early detection of pregnancy," which means it diagnoses a condition rather than treating it.
Yes
This device is described as an "In Vitro diagnostic test for the qualitative detection of hCG in human urine to aid in the early detection of pregnancy." The explicit mention of "diagnostic test" directly indicates its diagnostic purpose.
No
The 510(k) summary describes an In Vitro diagnostic test kit, which is a physical device used to detect hCG in urine. It does not describe a software-only medical device.
Yes, based on the provided information, the Ameditech ImmuTest™ hCG Pregnancy Test is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states it is an "In Vitro diagnostic test".
- Function: It is designed to detect a substance (hCG) in a sample (human urine) outside of the body, which is the core definition of an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Ameditech ImmuTest™ hCG Pregnancy Test is an In Vitro diagnostic test for the qualitative detection of hCG in human urine to aid in the early detection of pregnancy. The sensitivity of the ImmuTest™ hCG Pregnancy Test is 25 mIU/ml hCG. This test kit is used to obtain a visual, qualitative result and is intended for professional and Over-the-Counter uses.
Product codes
LCX; JHI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional and Over-the-Counter
Description of the training set, sample size, data source, and annotation protocol
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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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The sensitivity of the ImmuTest™ hCG Pregnancy Test is 25 mIU/ml hCG.
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 098 Gaither Road Rockville MD 20850
NOV 1 8.2002
John Wu. Ph.D. Director of Ouality Assurance Ameditech, Inc. 10340 Camino Santa Fe, Suite F San Diego, CA 92121
K023126 Trade/Device Name: Ameditech ImmuTest™ hCG Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX; JHI Dated: September 16, 2002 Received: September 19, 2002
Dear Dr. Wu:
Re:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and 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 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/cdrl/dsmaldsmamain.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
2
Attachment A
Revised Indications for Use Form
510(k) Number (if known):
Ameditech ImmuTest™ hCG Pregnancy Test Device Name:
2023121,
Indications For Use:
The Ameditech ImmuTest™ hCG Pregnancy Test is an In Vitro diagnostic test for the qualitative detection of hCG in human urine to aid in the early detection of pregnancy. The sensitivity of the ImmuTest™ hCG Pregnancy Test is 25 mIU/ml hCG.
This test kit is used to obtain a visual, qualitative result and is intended for professional and Over-the-Counter uses.
(Division Sign-Off)
Division of Clinical Laboratd
510(k) Number K03120
(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)
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