(125 days)
Not Found
No
The summary describes a qualitative immunoassay read by an analyzer, with no mention of AI or ML in the intended use, device description, or specific sections for AI/ML information.
No
The device is an in vitro diagnostic test for qualitative detection of hCG in urine, which is used for diagnosis, not treatment, of a condition.
Yes
The "Intended Use / Indications for Use" states it is "for in vitro diagnostic use."
No
The device description explicitly states it is a "qualitative test" read by the "Clinitek Status instrument," indicating it is a physical test kit and an analyzer, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The Bayer Healthcare Clinitest hCG Pregnancy Test is for in vitro diagnostic use as a qualitative method in the rapid detection of human chorionic gonadotropin (hCG) in urine specimens."
This statement directly identifies the device as being for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
The Bayer Healthcare Clinitest hCG Pregnancy Test is for in vitro diagnostic use as a qualitative method in the rapid detection of human chorionic gonadotropin (hCG) in urine specimens. The test is utilized with the Clinitest Status analyzer and is intended for near patient (point of care) and centralized laboratory locations.
Product codes (comma separated list FDA assigned to the subject device)
JHI
Device Description
The Clinitest® hCG is a qualitative test for the rapid detection of human chorionic gonadotropin (hCG) in urine. The device is read by the Clinitek Status instrument.
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
near patient (point of care) and centralized laboratory locations.
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.
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
DEC 2 3 2003
Appendix A Summary of Safety and Effectiveness
As required by 21 CFR 807.92, the following 510(k) Summary is provided:
1. Submitters Information
| Contact person: | Mary E. Gray, RAC
NPT Regulatory Affairs Manager |
|------------------------|---------------------------------------------------------------------------------------------------|
| Address: | Bayer Healthcare, LLC
Subsidiary of Bayer Corporation
63 North Street
Medfield, MA 02052 |
| Phone: | (508) 359-3826 |
| Fax: | (508) 359-3776 or (508) 359-3356 |
| e-mail address: | mary.gray.b@bayer.com |
| Date Summary Prepared: | November 7, 2003 |
| 2. Device Information | |
〜に〜it
| Proprietary Name: | Clinitest® hCG Pregnancy Test |
|---|---|
| Common Name: | hCG Test System |
| Classification Name: | Radioimmunoassay, Human Chorionic Gonadotropin |
| Classification Number: | 21 CFR 862.1155, Class II |
| Classification Panel: | Clinical Chemistry and Clinical Toxicology |
3. Predicate Device Information
| Device Name: | Clinitest hCG Pregnancy
Test | Quidel QuickVue One-Step
hCG Combo |
|-------------------|---------------------------------|---------------------------------------|
| Manufacturer: | Bayer Healthcare, LLC | Quidel Corporation |
| 510(k)
Number: | # K023944 | # K020801 |
1
Appendix A Summary of Safety and Effectiveness
4. Device Description
The Clinitest® hCG is a qualitative test for the rapid detection of human chorionic gonadotropin (hCG) in urine. The device is read by the Clinitek Status instrument.
5. Statement of Intended Use
The Bayer Healthcare Clinitest hCG Pregnancy Test is for in vitro diagnostic use as a qualitative method in the rapid detection of human chorionic gonadotropin (hCG) in urine specimens. The test is utilized with the Clinitest Status analyzer and is intended for near patient (point of care) and centralized laboratory locations.
6. Summary of Technological Characteristics
The Clinitest hCG Pregnancy Test is similar in technological characteristics, device performance and intended use, therefore, is substantially equivalent to the predicate performanoo and intenace ass, nency Test (# K023944) and the Quidel QuickVue One-Step hCG Combo test (# K020801).
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 3 2003
Ms. Mary E. Gray NPT Regulatory Affairs Manager Bayer Healthcare, LLC Subsidiary of Bayer Corporation 63 North Street Medfield, MA 02052
K032563 Re: Trade/Device Name: Clinitest® hCG Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI Dated: November 7, 2003 Received: November 10, 2003
Dear Ms. Gray:
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.
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).
3
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
INDICATIONS FOR USE STATEMENT
| 510(k) Number (if known): | K032563 |
|---|---|
| --------------------------- | --------- |
Bayer Healthcare Clinitest® hCG Pregnancy Test Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The Bayer Healthcare Clinitest hCG Pregnancy Test is for in vitro diagnostic use a r he Bayer Fredit four of human chorionic gonadotropin (hCG) in unne qualitatio mother in used to obtain a Clinitek Status analyzer result of positive, borderline or negative and is intended for near patient (point-of-care) and centralized laboratory locations.
(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)
Carol C Benson
Division Sign-Of
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) /