Question 1

What types of medical devices does OSANG Healthcare manufacture?

Accepted Answer

OSANG Healthcare specializes in in vitro diagnostic (IVD) devices primarily for home use. Their portfolio includes glucose monitoring systems such as meters, test strips, and control solutions for diabetes management. They also produce rapid antigen test kits for self-testing SARS-CoV-2 (COVID-19) detection, as well as multi-genus respiratory virus antigen tests designed for both at-home and clinical use. Additionally, they offer cholesterol testing kits using chemiluminescent immunoassay technology.

Question 2

Where is OSANG Healthcare based, and what does that mean for their regulatory oversight?

Accepted Answer

OSANG Healthcare is based in the United States, which means their devices fall under FDA regulatory jurisdiction. Since they manufacture IVDs, their products are authorised through the FDA’s 510(k) premarket notification process and are listed in the FDA’s Unique Device Identifier (UDI) database. This reflects compliance with U.S. medical device regulations.

Question 3

Which regulatory registries list OSANG Healthcare’s devices, and why?

Accepted Answer

OSANG Healthcare’s devices are listed in the FDA’s 510(k) and UDI registries. The 510(k) registry documents premarket submissions for devices deemed substantially equivalent to legally marketed predicates, while the UDI system ensures traceability and identification of devices throughout their lifecycle. Listing in these registries confirms their compliance with U.S. regulatory requirements for authorised medical devices.

Question 4

How are OSANG Healthcare’s devices classified under FDA regulations?

Accepted Answer

OSANG Healthcare’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body system it interacts with, as outlined in the FDA’s regulatory framework.

Question 5

What kinds of diagnostic tests does OSANG Healthcare offer for respiratory viruses?

Accepted Answer

OSANG Healthcare offers rapid in vitro diagnostic (IVD) kits for detecting respiratory viruses, including SARS-CoV-2 (COVID-19) and other multi-genus respiratory pathogens. These tests are designed for self-testing at home or clinical use, using antigen detection technology via rapid immunochromatographic tests (ICT). The kits are authorised for identifying specific viral antigens to aid in early diagnosis and infection monitoring.

Device	Model / Reference	Registries	Class	Status
OKRA Pro Glucose meter	IGM-1003F	FDA UDI	Class II	Active
OKRA Glucose Test Strip	IGM-1003A	FDA UDI	Class II	Active
CURO L5 TG test strip	ILM-0001A	FDA UDI	Class I	Active
CURO L5 TC test strip	ILM-0001A	FDA UDI	Class I	Active
Element™Plus Test Strips	IGM-0021B	FDA UDI	Class II	Active
Element™ Meter	IGM-0021B	FDA UDI	Class I	Active
Oh'Care Lite Smart Glucose control solution-Level 1	IGM-1003F	FDA UDI	Class I	Active
Oh'Care Lite Smart Glucose Test Strip	IGM-1003F	FDA UDI	Class II	Active
QuickFinder COVID-19 Antigen Self Test	OI-01SA-SH	FDA UDI	N/A	Active
Oh'Care Lite Smart Glucose control solution-Level 2	IGM-1003F	FDA UDI	Class I	Active
QuickFinder™ COVID-19/Flu Antigen Pro Control Swab Kit	OI-01SQ-C1	FDA UDI	Class I	Active
QuickFinder COVID-19 Antigen Self Test	OI-01SA-SH	FDA UDI	N/A	Active
QuickFinder™ COVID-19/Flu Antigen Self Test	OI-01SU-CC	FDA UDI	Class II	Active
QuickFinder™ COVID-19/Flu Antigen Self Test	OI-01SU-CC	FDA UDI	Class II	Active
OHC COVID-19 Antigen Self Test	OI-01SA-SH	FDA UDI	N/A	Active
Oh’Care Lite Glucose Control Solution	IGM-1003A	FDA UDI	Class I	Active
QuickFinder COVID-19 Antigen Self Test	OI-01SA-SH	FDA UDI	N/A	Active
QuickFinder COVID-19 Antigen Self Test	OI-01SA-SH	FDA UDI	N/A	Active
QuickFinder™ COVID-19/Flu Antigen Self Test	OI-01SU-CC	FDA UDI	Class II	Active
OKRA Glucose Test Strip Refill kit	IGM-1003A	FDA UDI	Class II	Active
OHC COVID-19 Antigen Self Test	OI-01SA-SH	FDA UDI	N/A	Active
OKRA Glucose Test Strip(25T)	IGM-1003A	FDA UDI	Class II	Active
OHC COVID-19 Antigen Self Test	OI-01SA-SH	FDA UDI	N/A	Active
OKRA Glucose monitoring system starter kit	IGM-1003A	FDA UDI	Class II	Active
Oh’Care Lite Blood Glucose Monitoring System for Self-Testing	IGM-1003A	FDA UDI	Class II	Active
QuickFinder™ COVID-19/Flu Antigen ProTest	OI-01SU-CC	FDA UDI	Class II	Active
Oh’Care Lite Blood Glucose Test strips	IGM-1003A	FDA UDI	Class II	Active
Oh'Care Lite Smart Glucose monitoring system	IGM-1003F	FDA UDI	Class II	Active
QuickFinder COVID-19 Antigen Self Test	OI-01SA-SH	FDA UDI	N/A	Active
QuickFinder™ COVID-19/Flu Antigen Self Test	OI-01SU-CC	FDA UDI	Class II	Active
Oh'care Lite Smart Glucose Test Strip	IGM-1003F	FDA UDI	Class II	Active
OHC COVID-19/ Flu Antigen Test Pro	OI-01SU-CC	FDA UDI	N/A	Active
Oh'care Lite Smart Glucose Meter	IGM-1003F	FDA UDI	Class II	Active
OHC COVID-19 Antigen Self Test	OI-01SA-SH	FDA UDI	N/A	Active
OKRA Pro Glucose monitoring system starter kit	IGM-1003F	FDA UDI	Class II	Active
Element™ Test Strips	IGM-0021B	FDA UDI	Class II	Active
Oh'Care Lite Smart Glucose control solution-Level 3	IGM-1003F	FDA UDI	Class I	Active
Oh’Care Lite Blood Glucose Monitoring System Kit	IGM-1003A	FDA UDI	Class I	Active
OHC COVID-19 Antigen Self Test	OI-01SA-SH	FDA UDI	N/A	Active
CURO L5 Glucose test strip	ILM-0001A	FDA UDI	Class II	Unknown
Element™Plus Meter	IGM-0021B	FDA UDI	Class II	Active
CURO L5 Meter	ILM-0001A	FDA UDI	Class I	Active
OKRA Glucose meter	IGM-1003A	FDA UDI	Class II	Active
Finetest Lite Smart Blood Glucose Monitoring System	K201396	FDA 510(k)	Class II	Active
Finetest Lite Blood Glucose Monitoring System	K203562	FDA 510(k)	Class II	Active
Oh'Care Lite Smart Blood Glucose Monitoring System	K182286	FDA 510(k)	Class II	Active

OSANG HEALTHCARE Co., Ltd.

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