Question 1

What types of medical devices does Philosys, Inc. manufacture?

Accepted Answer

Philosys, Inc. specializes in in vitro diagnostic (IVD) blood glucose monitoring systems intended for home use. These include strip-based meters, control solutions for calibration (like the Gmate® Control Solution Level 3), and advanced systems with features such as voice feedback (e.g., Gmate® VOICE) or smart connectivity (e.g., GlucoTrack SMART). The devices are designed to help users monitor blood glucose levels independently.

Question 2

Where is Philosys, Inc. based, and what regulatory pathways do its devices follow?

Accepted Answer

Philosys, Inc. is headquartered in the United States. Its devices are regulated under FDA pathways, including 510(k) clearances and de novo submissions, depending on the device’s risk classification. The company’s products are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries, reflecting their compliance with U.S. regulatory requirements for IVD blood glucose monitoring systems.

Question 3

Which regulatory registries list Philosys, Inc.’s devices?

Accepted Answer

Philosys, Inc.’s devices are included in the FDA’s official registries, specifically the 510(k) Premarket Notification database and the Unique Device Identifier (UDI) system. These registries track devices that have undergone FDA review and clearance processes, ensuring transparency about their regulatory status. The inclusion in these databases confirms the devices meet applicable U.S. regulatory standards.

Question 4

How are Philosys, Inc.’s blood glucose monitoring systems classified under FDA regulations?

Accepted Answer

Philosys, Inc.’s blood glucose monitoring systems are classified as either Class I or Class II devices under FDA regulations. The classification depends on the device’s risk level and intended use. For example, simpler meters or control solutions may fall under Class I, while more complex systems (e.g., those with advanced connectivity or automated features) may be classified as Class II, requiring additional regulatory scrutiny to ensure safety and performance.

Device	Model / Reference	Registries	Class	Status
Gmate® Control Solution Level 3	PC-003	FDA UDI	Class I	Active
Gmate® Origin Blood Glucose Monitoring System	PG-310	FDA UDI	Class II	Active
Gmate® SMART Blood Glucose Monitoring System	PG-101	FDA UDI	Class II	Active
Gmate® VOICE Blood Glucose Monitoring System	PG-301	FDA UDI	Class II	Active
Gmate® Control Solution Level 2	PC-002	FDA UDI	Class I	Active
GlucoTrack Solution Level 3	GT-C03	FDA UDI	Class I	Active
GlucoTrack SMART Blood Glucose Monitoring System	GT-101	FDA UDI	Class II	Active
Gmate® mini Blood Glucose Monitoring System	PG-200	FDA UDI	Class II	Active
Pip Control Solution Normal	PC002-US	FDA UDI	Class I	Active
Gmate® Origin Blood Glucose Monitoring System	PG-310	FDA UDI	Class II	Active
Gmate® STEP Blood Glucose Monitoring System	PG-201	FDA UDI	Class II	Active
Gmate® STEP Blood Glucose Monitoring System	PG-201	FDA UDI	Class II	Active
Gmate® STEP Blood Glucose Monitoring System	PG-201	FDA UDI	Class II	Active
GlucoTrack Blood Glucose Test Strips	GT-S01	FDA UDI	Class II	Active
Pip Blood Glucose Monitoring System	PG-310	FDA UDI	Class II	Active
GlucoTrack VOICE Blood Glucose Monitoring System	GT-301	FDA UDI	Class II	Active
GlucoTrack Solution Level 1	GT-C01	FDA UDI	Class I	Active
GlucoTrack SMART Blood Glucose Monitoring System	GT-101	FDA UDI	Class II	Active
Gmate® Origin Blood Glucose Monitoring System	PG-310	FDA UDI	Class II	Active
GlucoTrack Solution Level 2	GT-C02	FDA UDI	Class I	Active
Gmate® Blood Glucose Test Strips	PS-004	FDA UDI	Class II	Active
Gmate Smart Blood Glucose Monitoring System	PG-101	FDA UDI	Class II	Active
Pip Control Solution Low	PC001-US	FDA UDI	Class I	Active
Gmate® mini Blood Glucose Monitoring System	PG-200	FDA UDI	Class II	Active
Gmate® mini Blood Glucose Monitoring System	PG-200	FDA UDI	Class II	Active
Pip Blood Glucose Test Strips	PS-004	FDA UDI	Class II	Active
Gmate® Blood Glucose Test Strips	PS-004	FDA UDI	Class II	Active
GlucoTrack Blood Glucose Test Strips	GT-S01	FDA UDI	Class II	Active
GlucoTrack VOICE Blood Glucose Monitoring System	GT-301	FDA UDI	Class II	Active
Gmate® VOICE Blood Glucose Monitoring System	PG-301	FDA UDI	Class II	Active
Gmate® SMART Blood Glucose Monitoring System	PG-101	FDA UDI	Class II	Active
Gmate® SMART Blood Glucose Monitoring System	PG-101	FDA UDI	Class II	Active
GlucoTrack SMART Blood Glucose Monitoring System	GT-101	FDA UDI	Class II	Active
GlucoTrack Voice Blood Glucose Monitoring System	GT-301	FDA UDI	Class II	Active
Gmate® VOICE Blood Glucose Monitoring System	PG-301	FDA UDI	Class II	Active
Pip Control Solution High	PC003-US	FDA UDI	Class I	Active
Gmate® Control Solution Level 1	PC-001	FDA UDI	Class I	Active
Gmate Mini Blood Glucose Monitoring System, Gmate Step Blood Glucose Monitoring System	K141656	FDA 510(k)	Class II	Active
Blood Glucose Monitoring System (glucose Oxidase)	K113636	FDA 510(k)	Class II	Active
Gmate SMART Blood Glucose Monitoring System	K150299	FDA 510(k)	Class II	Active
Gmate Origin Blood Glucose Monitoring System	K151658	FDA 510(k)	Class II	Active
Gmate Smart Blood Glucose Monitoring System, Gmate Smart Application	K131230	FDA 510(k)	Class II	Active

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