(36 days)
Not Found
Not Found
No
The device description and intended use describe a simple immunochromatographic test, and there are no mentions of AI, ML, or image processing.
No
The device is a diagnostic test for early detection of pregnancy, not a therapeutic device. It does not treat or cure any condition.
Yes
The device is described as allowing "qualitative determination of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy," which is a diagnostic purpose.
No
The device description clearly states it uses "color immunochromatographic technology with antibodies coated on the membrane" and a "blue test line will appear". This indicates a physical test strip or similar hardware component, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "qualitative determination of human chorionic gonadotropin (hCG) in urine". This involves testing a sample (urine) taken from the body in vitro (outside the body) to diagnose a condition (pregnancy).
- Device Description: The description mentions using "color immunochromatographic technology with antibodies coated on the membrane". This is a common method used in IVD tests to detect specific substances in biological samples.
- Predicate Devices: The mention of predicate devices like the "Quidel RapidVue hCG Test" and "Abbott TestPack Plus hCG Urine Test" further confirms its classification as an IVD, as these are well-known IVD pregnancy tests.
The core function of analyzing a biological sample (urine) outside the body to provide diagnostic information (presence of hCG for pregnancy detection) is the defining characteristic of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The OSOM™ Classic hCG-Urine Test is intended for the qualitative determination of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy.
Product codes (comma separated list FDA assigned to the subject device)
75JHI
Device Description
OSOM Classic hCG-Urine Test uses color immunochromatographic technology with antibodies coated on the membrane. If hCG is present in urine, a blue test line will appear to indicate a positive result.
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
Not Found
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/0 description: The image shows the logo for Wyntek diagnostics. The logo consists of a circular icon on the left and the word "Wyntek" in bold, sans-serif font on the right. Below "Wyntek" is the word "diagnostics" in a smaller, sans-serif font. The icon appears to be a stylized representation of a medical or diagnostic symbol.
EFR - 1997
510 (k) Summary 8.
Ⓑ 619.452.3198
Ⓕ 619.452.3258
Wyntek Diagnostics Inc
ISO9001 EN46001 Certified
6146 Nancy Ridge Drive Suite 101 San Diego California 92121 USA
Submitter : Wyntek Diagnostics, Inc. 6146 Nancy Ridge Dr. Ste. 101 San Diego, CA 92121 Tel: 619-452-3198 Fax: 619-452-3258
Contact Person: Shu-Ching Cheng
Product Name:
| Proprietary Name: | OSOM TM Classic hCG-Urine Test |
|---|---|
| Common Name: | hCG Urine Pregnancy Test Kit |
| Classification Name: | Human chorionic gonadotropin (hCG) test |
| Classification Number: | 75JHI |
Intended Use: The OSOM™ Classic hCG-Urine Test is intended for the qualitative determination of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy.
Description: OSOM Classic hCG-Urine Test uses color immunochromatographic technology with antibodies coated on the membrane. If hCG is present in urine, a blue test line will appear to indicate a positive result.
Substantial Equivalence:
OSOM Classic hCG-Urine Test is substantially equivalent to Quidel RapidVue hCG Test and Abbott TestPack Plus hCG Urine Test. All three tests utilize immunochromatographic technology and anti-hCG antibodies to detect hCG in urine. All three tests interpret the results through the development of the color lines.
SL-Char Applicant Signed: clare Date: 114/97 Shu-Ching Cheng