(312 days)
No
The description focuses on standard immunoassay and digital readout technology, with no mention of AI/ML terms or concepts. The software validation mentioned is likely for the digital display and not for complex algorithmic processing.
No
This device is an in vitro diagnostic test for the qualitative determination of human chorionic gonadotropin (hCG) in urine, used to aid in the early detection of pregnancy, and does not provide therapeutic treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the devices are "in vitro diagnostic test device[s] for the qualitative determination of human chorionic gonadotropin (hCG) in urine." This directly identifies them as diagnostic devices.
No
The device description explicitly states that the FORA PNC100 Digital Pregnancy Test consists of a "meter and a plastic test stick containing a test strip," indicating the presence of hardware components beyond just software.
Yes, based on the provided text, both the FORA PNC100 Digital Pregnancy Test and the TD-5301 Pregnancy Test are explicitly stated to be IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use / Indications for Use: Both sections clearly state that the devices are "in vitro diagnostic test device[s]".
- Device Description: This section also refers to them as "in vitro diagnostic medical devices".
The definition of an IVD is a medical device used to perform tests on samples such as blood, urine, or tissue to detect diseases or other conditions. These devices fit that description perfectly as they test urine for the presence of hCG to detect pregnancy.
N/A
Intended Use / Indications for Use
For FORA PNC 100 Digital Pregnancy Test
The FORA PNC100 Digital Pregnancy Test is an in vitro diagnostic test device for the qualitative determination of human chorionic gonadotropin (hCG) in urine. It is intended for use as an aid in the early detection of pregnancy by lay users. Additional clinical examination should be performed to confirm the pregnancy.
The device uses visually read lateral flow technology for the detection of hCG and provides a digitally read result. The device is intended for home use.
For TD-5301 Pregnancy Test
The TD-5301 Pregnancy Test (Strip) is an in vitro diagnostic test device for the qualitative determination of human chorionic gonadotropin (hCG) in urine. It is intended for use as an aid in the early detection of pregnancy by lay users. Additional clinical examination should be performed to confirm the pregnancy.
The device uses visually read lateral flow technology for the detection of hCG. The device is intended for home use.
Product codes
LCX
Device Description
The FORA PNC100 Digital Pregnancy Test and TD-5301 Pregnancy Test are in vitro diagnostic medical devices, which use the qualitative assay in determining human chorionic gonadotropin (hCG) concentration in urine. The assay is based on an two-site sandwich immunoassay technology.
TD-5301 Pregnancy Test consists of a test strip coated with reagents and enclosed in a plastic cassette. FORA PNC100 Digital Pregnancy Test consists of a meter and a plastic test stick containing a test strip. The meter has a slot where can be plugged with a test stick and activate the procedure. This device uses the same test strip, as TD-5301 Pregnancy Test.
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
lay users.
home 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)
A method comparison was performed by two proposed devices and the predicate. Results show that there is over 99% agreement compared with the predicate. The visual reading of lines of TD-5301 by lay users yields the same results as the digital readout obtained by FORA PNC100.
Test strip used with FORA PNC100 Digital Pregnancy Test and TD-5301 Pregnancy Test is identical. The sensitivity, specificity and interference, in-use and storage stability studies were tested and verified with both the proposed devices.
Software validation and meter reliability was performed specifically to ensure the performance of FORA PNC100 electronic read-out result. The meter of FORA PNC100 Digital Pregnancy Test meets the safety and EMC requirements of IEC/EN 61010-1:2001, IEC/EN 61010-2-101:2002, EN 61326: 2006, IEC 61000-4-2.
A user study was conducted to evaluate two application methods and the easiness of use by following the instructions, and the results demonstrated that the instruction manual of FORA PNC100 Digital Pregnancy Test and TD-5301 Pregnancy Test is understandable and clear enough for user, and devices are easy to operate by following the instructions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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OCT - 4 2011
Attachment A2
510 (k) Summary
1. Submitter Information Company name TaiDoc Technology Corporation Contact person Teling Hsu 3F, 5F, No. 127, Wugong 2nd Rd., Address Wugu Township, Taipei County, . 24888, Taiwan Phone (+886-2) 2-6625-8188 ext.1176 FAX (+886-2) 2-6625-0288 E-mail teling.hsu@taidoc.com.tw November 22nd, 2010 Date Prepared
- Name of Device Trade Names
Common Names Product Code Classification Panel and
Regulations
- Predicate Device Trade/Proprietary Name: Common/Usual Name: Submitter 510 (k) Number
FORA PNC100 Digital Pregnancy Test TD-5301 Pregnancy Test Pregnancy Test LCX Human chorionic gonadotropin (hCG) test system Clinical Chemistry Class II 21 CFR 862.1155
One Step HCG Urine Pregnancy Test Kit, Pregnancy Test, Over-the -Counter BLUE CROSS BIO-MEDICAL CO., LTD. K071930
1
4. Device Description
The FORA PNC100 Digital Pregnancy Test and TD-5301 Pregnancy Test are in vitro diagnostic medical devices, which use the qualitative assay in determining human chorionic gonadotropin (hCG) concentration in urine. The assay is based on an two-site sandwich immunoassay technology.
TD-5301 Pregnancy Test consists of a test strip coated with reagents and enclosed in a plastic cassette. FORA PNC100 Digital Pregnancy Test consists of a meter and a plastic test stick containing a test strip. The meter has a slot where can be plugged with a test stick and activate the procedure. This device uses the same test strip, as TD-5301 Pregnancy Test.
5. Intended Use
For FORA PNC 100 Digital Pregnancy Test
The FORA PNC100 Digital Pregnancy Test is an in vitro diagnostic test device for the qualitative determination of human chorionic gonadotropin (hCG) in urine. It is intended for use as an aid in the early detection of pregnancy by lay users. Additional clinical examination should be performed to confirm the pregnancy.
The device uses visually read lateral flow technology for the detection of hCG and provides a digitally read result. The device is intended for home use.
For TD-5301 Pregnancy Test
The TD-5301 Pregnancy Test (Strip) is an in vitro diagnostic test device for the qualitative determination of human chorionic gonadotropin (hCG) in urine. It is intended for use as an aid in the early detection of pregnancy by lay users. Additional clinical examination should be performed to confirm the pregnancy.
The device uses visually read lateral flow technology for the detection of hCG. The device is intended for home use.
6. Comparison to Predicate Device
A method comparison was performed by two proposed devices and the predicate. Results show that there is over 99% agreement compared with the predicate. The
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visual reading of lines of TD-5301 by lay users yields the same results as the digital readout obtained by FORA PNC100. The FORA PNC100 Digital Pregnancy Test and TD-5301 Pregnancy Test are substantially equivalent to the One Step HCG Urine Pregnancy Test (K071930).
7. Performance Studies
Test strip used with FORA PNC100 Digital Pregnancy Test and TD-5301 Pregnancy Test is identical. The sensitivity, specificity and interference, in-use and storage stability studies were tested and verified with both the proposed devices.
Software validation and meter reliability was performed specifically to ensure the performance of FORA PNC100 electronic read-out result. The meter of FORA PNC100 Digital Pregnancy Test meets the safety and EMC requirements of IEC/EN 61010-1:2001, IEC/EN 61010-2-101:2002, EN 61326: 2006, IEC 61000-4-2.
A user study was conducted to evaluate two application methods and the easiness of use by following the instructions, and the results demonstrated that the instruction manual of FORA PNC100 Digital Pregnancy Test and TD-5301 Pregnancy Test is understandable and clear enough for user, and devices are easy to operate by following the instructions.
8. Conclusion
The FORA PNC100 Digital Pregnancy Test and TD-5301 Pregnancy Test demonstrate satisfactory performance and are suitable for its intended use. The FORA PNC100 Digital Pregnancy Test and TD-5301 Pregnancy Test are substantially equivalent to the predicate device.
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Image /page/3/Picture/1 description: The image shows a logo with a stylized bird in flight on the right side. The bird is composed of three curved lines that suggest movement and feathers. To the left of the bird, there is a circular arrangement of text that appears to be the name of an organization or agency. The text is small and curves along the circle's perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
OCT 04 2011
TaiDoc Technology Corporation c/o Teling Hsu Manager, Regulatory Affairs 3F, SF, No. 127, Wugong 2nd Rd. Wugu Township. Taipei County 24888 Taiwan
Re: K103487
Trade Name: Fora PNC100 Digital Pregnancy Test; TD-5301 Pregnancy Test Strip Regulation Number: 21 CFR 862.1345 Regulation Name: Human chorionic gonadotropin test system Regulatory Class: II Product Codes: LCX Dated: September 22, 2011 Received: September 27, 2011
Dear Teling Hsu:
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 111 (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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (2) CFR Parl 801), please contact the Office of In Virro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please nate the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the revoring of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (196-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resources[orYou/Industry/default.htm.
Sincerely yours,
j
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Attachment A1
Indications for Use
510(k) Number: K103487
Device Name: FORA PNC100 Digital Pregnancy Test
Indications for Use:
The FORA PNC100 Digital Pregnancy Test is an in vitro diagnostic test device for the qualitative determination of human chorionic gonadotropin (hCG) in urine. It is intended for use as an aid in the early detection of pregnancy by lay users. Additional clinical examination should be performed to confirm the pregnancy.
This device uses visually read lateral flow technology for the detection of hCG and provides a digitally read result. The device is intended for home use.
Prescription Use __ (21 CFR Part 801 Subpart D) AND/OR
Over the Counter Use X (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Ruth Checler
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) jo3487
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1
6
Indications for Use
510(k) Number: K103487
Device Name: TD-5301 Pregnancy Test
Indications for Use:
The TD-5301 Pregnancy Test (Strip) is an in vitro diagnostic test device for the qualitative determination of human chorionic gonadotropin (hCG) in urine. It is intended for use as an aid in the early detection of pregnancy by lay users. Additional clinical examination should be performed to confirm the pregnancy.
This device uses visually read lateral flow technology for the detection of hCG. The device is intended for home use.
Prescription Use __ (21 CFR Part 801 Subpart D) AND/OR
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Rute Chaler
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety ( 03 510(k) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =
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