(143 days)
Not Found
Not Found
No
The summary describes a qualitative, visual immunoassay test kit for pregnancy detection, with no mention of AI, ML, image processing, or any computational analysis beyond visual interpretation.
No.
Explanation: The device is a diagnostic test kit for early detection of pregnancy, not a therapeutic device.
Yes
Explanation: The intended use states that the test kit is for "early detection of pregnancy" and provides a "visual and qualitative result," which are characteristics of a diagnostic device. It's used to determine a medical condition.
No
The device description and intended use clearly describe a physical test kit (cassette) for detecting hCG in serum and urine, indicating it is a hardware-based medical device, not software-only.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "test kit for rapid determination of hCG concentration... in both serum and urine for early detection of pregnancy." This involves testing biological samples (serum and urine) in vitro (outside the body) to diagnose a condition (pregnancy).
- Clinical Lab Use: The intended user is specified as "clinical lab used," which is a common setting for IVD testing.
The description aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
PS - UNIT CASSETTE/ Serum and Urine Combo HCG test is a qualitative, two ne and the blogs as accesses test kit for rapid determination of hCG concect to PS - UNT CASSETTE/ Serum and Urine Combo HCG test is a qualification sites sandwich images ay test kit for rapid determination of hCG conceration of the same begine for esty sites sandwich immunoassy test kit for rapid determination of new to in both serum and wine for early detection of pregnancy. This test kit is used to in both serum and secur in both serum and urine for early detection of progently of the your by obtain a visual and qualitative result and is for clinical lab used.
Product codes
JHI
Device Description
Not Found
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
clinical lab used
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
Not Found
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).
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 1 3 1998
Benny Wang Research Assistant International Newtech Development, Inc. 1629 Fosters Way Delta, B.C. Canada V3M 6S7
Re : K974009 PS-UNIT CASSETTE/Serum and Urine Combo HCG Regulatory Class: II Product Code: JHI Dated: January 20, 1998 January 27, 1998 Received:
Dear Mr. Wang:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), 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 895. ਰੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic
Product Radiation Control provisions, or other Federal laws or requlations.
1
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
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
| 510(k) Number (if known): | 974009 |
|---|---|
| Device Name: | One Step Serum / urine Combo HCG Cassette Test |
Indications For Use:
PS - UNIT CASSETTE/ Serum and Urine Combo HCG test is a qualitative, two
ne and the blogs as accesses test kit for rapid determination of hCG concect to PS - UNT CASSETTE/ Serum and Urine Combo HCG test is a qualification
sites sandwich images ay test kit for rapid determination of hCG conceration
of the same begine for esty sites sandwich immunoassy test kit for rapid determination of new to
in both serum and wine for early detection of pregnancy. This test kit is used to
in both serum and secur in both serum and urine for early detection of progently of the your by
obtain a visual and qualitative result and is for clinical lab used.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEFDED)
THE OF WRITE BELOW THIS LINE - CONTINUE OF Closics (ODE)
NOT WEES of CDRH, Office of Device Evaluation (ODE)
OR
(Division Sign Off)
Division of Clinical Laboratory Devices
510(k) Number K97405
. I
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use_
(Optional Formal 1-2-96)