(182 days)
Not Found
Not Found
No
The device description details a simple immunochromatographic assay based on antibody binding and color change, with no mention of AI or ML technologies.
No
The device is described as an immunochromatographic assay for the qualitative detection of Group A Streptococcal antigen, indicating it is a diagnostic tool, not a device used for therapy or treatment.
Yes
The device is described as an "immunochromatographic assay for the qualitative detection of Group A Streptococcal antigen," which indicates its use in identifying a disease-causing agent, thus serving a diagnostic purpose.
No
The device description clearly indicates it is a physical immunochromatographic assay using dip stick technology with antibodies coated on a membrane, which is a hardware component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of Group A Streptococcal antigen from throat swabs or confirmation of presumptive Group A Streptococcal colonies from culture." This involves testing a sample taken from the body (in vitro) to diagnose a condition (Group A Streptococcus infection).
- Device Description: The description details an "immunochromatographic assay" that uses antibodies to detect the presence of an antigen in a sample. This is a common method used in IVD tests.
- Sample Type: The test uses "throat swabs" and "presumptive Group A Streptococcal colonies from culture," which are biological samples tested outside of the body.
These characteristics clearly align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
OSOM Strep A Test is an immunochromatographic assay for the qualitative detection of Group A Streptococcal antigen from throat swabs or confirmation of presumptive Group A Streptococcal colonies from culture.
Product codes
Not Found
Device Description
OSOM Strep A Test uses color immunochromatographic dip stick technology with antibodies coated on the membrane. If group A Streptococcus is present in the swab sample, 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
throat swabs
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3740
Streptococcus spp. serological reagents.(a)
Identification. Streptococcus spp. serological reagents are devices that consist of antigens and antisera (excluding streptococcal exoenzyme reagents made from enzymes secreted by streptococci) used in serological tests to identifyStreptococcus spp. from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genusStreptococcus and provides epidemiological information on these diseases. Pathogenic streptococci are associated with infections, such as sore throat, impetigo (an infection characterized by small pustules on the skin), urinary tract infections, rheumatic fever, and kidney disease.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
0
Image /page/0/Picture/0 description: The image shows the logo for Wyntek diagnostics. The logo consists of a circular icon with a stylized figure inside, followed by the word "Wyntek" in bold, sans-serif font. Below "Wyntek" is the word "diagnostics" in a smaller, lighter font. The logo is black and white.
OCT 11 1996
P 619.452.3198
F 619.452.3258
6146 Nancy Ridge Drive Suite 101 San Diego California
92121
USA
stics
Whintek
510 (k) Summary
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:
OSOM™ Strep A Test Proprietary Name; Common Name: Rapid Immunoassay for Group A Streptococcal Antigen Test Kit Classification Name: Antigens, All Groups, Streptococcus spp.
Intended Use:
OSOM Strep A Test is an immunochromatographic assay for the qualitative detection of Group A Streptococcal antigen from throat swabs or confirmation of presumptive Group A Streptococcal colonies from culture.
Description:
OSOM Strep A Test uses color immunochromatographic dip stick technology with antibodies coated on the membrane. If group A Streptococcus is present in the swab sample, a blue test line will appear to indicate a positive result.
-27-
1
Substantial Equivalence:
The OSOM Strep A Test is substantially equivalent to results obtained through isolation of Group A Streptococcus colonies on sheep blood agar medium followed by a serological grouping of presumptive Group A Streptococcus. Serotyping is used to confirm identity of presumptive Group A Streptococcus isolates.
These techniques and OSOM Strep A are substantially equivalent in that:
- a. Both are intended for use in the detection of Group A Streptococcus.
- b. Both are in vitro tests.
The tests differ in that:
- a. OSOM Strep A can detect non-viable as well as viable organisms.
- b. Results cab be obtained in minutes using OSOM Strep A test. Culture methods to obtain comparable results require 18-24 hours or longer.
Applicant Signed: S.L. Date: April 11, 1996
Shu-Ching Cheng