(242 days)
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No
The description clearly states it is a self-testing immunoassay, which is a chemical-based test, and there is no mention of AI, ML, or any computational analysis of data.
No
The device is a diagnostic tool for detecting pregnancy and does not provide any treatment or therapy.
Yes
A diagnostic device is one that helps to identify a disease or condition. This device is used for the "qualitative determination of human chorionic gonadotropin (HCG) in the urine to aid in early detection of pregnancy," which is a physiological condition. Therefore, it is a diagnostic device.
No
The device description clearly states it is an "immunoassay," which is a laboratory technique that uses antibodies to measure the presence or concentration of a substance. This implies a physical test strip or component, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- It is a self-testing immunoassay: This means it's a test performed outside of the body using biological samples (urine in this case).
- It determines a substance in a biological sample (HCG in urine): This is a key characteristic of IVDs.
- It is used to aid in the early detection of pregnancy: This is a medical purpose.
- It is for over-the-counter use: While not all IVDs are over-the-counter, many are, and this indicates it's a diagnostic test intended for use by individuals.
The description clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
DAVID PREGNANCY TEST IS A SELF-TESTING IMMUNOASSAY DESIGNED FOR THE QUALITATIVE DETERMINATION OF HUMAN CHORIONIC GONADOTROPIN (HCG) IN THE URINE TO AID IN EARLY DETECTION OF PREGNANCY. IT IS FOR THE OVER-THE-COUNTER-USE
Product codes
LCX
Device Description
DAVID PREGNANCY TEST IS A SELF-TESTING IMMUNOASSAY DESIGNED FOR THE QUALITATIVE DETERMINATION OF HUMAN CHORIONIC GONADOTROPIN (HCG) IN THE URINE TO AID IN EARLY DETECTION OF PREGNANCY.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
SELF-TESTING / OVER-THE-COUNTER-USE
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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.
0
510(K) SUMMARY
JUL 1 8 2006
DATE OF SUMMARY: NOVEMBER 3, 2005
SUBMITTER & CORRESPONDENT IN THE UNITED STATES:
NATIONAL BUSINESS GROUP INC. 2941 6181. AVE NE TACOMA WA 98422 CONTACT# 253-238-6409
MANUFACTURED BY:
RUNBIO BIO TECH CO., LTD RONGSHENG TECHNOLOGICAL ZONE, UNIVERSITY ROAD SHANTOU, GUANGDONG, CHINA 515063
DEVICE NAME:
DAVID PREGNANCY TEST (STRIP AND MIDSTREAM)
DEVICECLASSIFICATION NAME:
PREGNANCY, TEST, KIT, HCG, MIDSTREAM, TEST STRIP, OVER-THE-COUNTER
CLASSIFICATION NUMBER: 862.1155
FDA PRODUCT CODE: LCX
MEDCAL SPECIALTY: CLINICAL CHEMISTRY
INTENDEND USE:
DAVID PREGNANCY TEST IS A SELF-TESTING IMMUNOASSAY DESIGNED FOR THE QUALITATIVE DETERMINATION OF HUMAN CHORIONIC GONADOTROPIN (HCG) IN THE URINE TO AID IN EARLY DETECTION OF PREGNANCY. IT IS FOR THE OVER-THE-COUNTER-USE
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, composed of three overlapping profiles facing to the right. The figure is positioned in the center of a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged around the upper half of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 2 6 2006
Runbio Biotech Co., Ltd. c/o Ms. Jessica Vagata National Business Group Inc. 2941 61st Ave. NE Tacoma, WA 98422
Re: K053236
Trade/Device Name: David Pregnancy Test (Strip and Midstream) Regulation Number: 21 CFR§ 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: June 19, 2006 Received: June 22, 2006
Dear Ms. Vagata:
This letter corrects our substantially equivalent letter of July 18, 2006.
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.
2
Page 2 - Ms. Jessica Vagata
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).
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 (240) 276-0484. 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/industry/support/index.html.
Sincerely vours,
Carol C. Bensenfor
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number: K053236
Device Name: DAVID PREGNANCY TEST (STRIP AND MIDSTREAM)
Indications For Use:
DAVID PREGNANCY TEST IS A SELF-TESTING IMMUNOASSAY DESIGNED FOR THE QUALITATIVE DETERMINATION OF HUMAN CHORIONIC GONADOTROPIN (HCG) IN THE URINE TO AID IN EARLY DETECTION OF PREGNANCY. IT IS FOR THE OVER-THE-COUNTER-USE
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use × (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) | |
|---|---|
| Division Sign-Off | |
| Office of In Vitro Diagnostic Device | |
| Evaluation and Safety | |
| 510(k) | K053236 |