Question 1

What types of medical devices does Arj Medical, Inc. manufacture?

Accepted Answer

Arj Medical, Inc. specializes in in vitro diagnostic (IVD) devices primarily focused on detecting *Helicobacter pylori* infections and analyzing breath samples. Their product line includes infrared spectrometry breath analyzers, carbon isotope breath test kits, and urease-based test kits (both rapid and chromogenic). They also produce urinalysis reagent strips and urine analyzers, which are used for general diagnostic testing.

Question 2

Where is Arj Medical, Inc. based, and how does that affect its regulatory compliance?

Accepted Answer

Arj Medical, Inc. is based in the United States, which means its devices are subject to regulation by the FDA. Since the company’s products fall under FDA categories like 510(k) clearances (for Class I devices) and PMA/PMA supplements (for Class III devices), compliance is governed by U.S. medical device laws. The FDA’s oversight ensures these devices meet safety, performance, and labeling requirements before they enter the market.

Question 3

Which regulatory registries or databases list Arj Medical, Inc.’s devices?

Accepted Answer

Arj Medical, Inc.’s devices are listed in key U.S. regulatory databases, including the FDA’s 510(k) clearance registry, PMA/PMA supplement registry, and the Unique Device Identifier (UDI) system. These registries ensure traceability and compliance tracking for devices like their breath analyzers and urease test kits, which are classified as either Class I or Class III under FDA guidelines.

Question 4

How are Arj Medical, Inc.’s devices classified under FDA regulations?

Accepted Answer

Arj Medical, Inc.’s devices are classified as either Class I or Class III under FDA regulations. Class I devices generally pose minimal risk and require less stringent oversight, such as 510(k) clearances for modifications. In contrast, Class III devices—such as some of their breath analyzers or urease test systems—are considered higher risk (e.g., supporting life-sustaining functions or presenting unreasonable risk of illness) and require Premarket Approval (PMA) or PMA supplements for authorization.

Question 5

Why are some of Arj Medical, Inc.’s devices listed under the FDA’s Unique Device Identifier (UDI) system?

Accepted Answer

The FDA’s UDI system assigns unique product identifiers to medical devices to improve tracking, reduce medical errors, and enhance transparency in the supply chain. Arj Medical’s breath analyzers and urea breath test systems are included in this system because they are high-risk or complex devices (e.g., Class III or those requiring precise traceability). UDIs ensure regulators, healthcare providers, and patients can quickly verify device details, compliance status, and recall information if needed.

Device	Model / Reference	Registries	Class	Status
PyloPlus+ Urea Breath Test Pro Analyzer	PPUBTA-16	FDA UDI	Class III	Active
PyloPlus+ Rapid Urease Test	PYLO-50	FDA UDI	Class I	Active
PyloPlus+ Urea Breath Test Analyzer	PPUBTA-02	FDA UDI	Class III	Active
PyloPlus+ Urea Breath Test Lab Analyzer	PPUBTLA-04	FDA UDI	Class III	Active
PyloPlus+ Urea Breath Test Kit	PPUBTK	FDA UDI	Class III	Active
Uterine Manipulator Injector Cannula, Sterile, Model R 57-450	K010056	FDA 510(k)	Class II	Active
Mmodification To Laminaria	K011512	FDA 510(k)	Class II	Active
Rocket Cervical Spatula	K884042	FDA 510(k)	Class II	Active
Rocket Intrauterine Depth Sound	K884684	FDA 510(k)	Class I	Active
Cannula, Surgical General & Plastic Surgery, Modelr65-995, R65-995-1, R65-995-2, R65-997, R65-997-1	K010789	FDA 510(k)	Class II	Active
Uritest 10 Urinalysis Reagent Strips	K052719	FDA 510(k)	Class I	Active
Rocket Intrauterine Sound	K883806	FDA 510(k)	Class I	Active
Rocket Endocervical Brush	K885274	FDA 510(k)	Class II	Active
Rocket Fetal Blood Sampling Tray	K884685	FDA 510(k)	Class II	Active
Insufflation Needle, Model R65-933	K000027	FDA 510(k)	Class II	Active
Tom Cat F.l., Tom Cat S.l.	K972245	FDA 510(k)	Class II	Active
Endocervical Block Needle	K973671	FDA 510(k)	Class II	Active
Balloon Cannula, Short, Model R65-985; Balloon Cannula, Long, Model R65-985-1	K010510	FDA 510(k)	Class II	Active
The Aspirator, 6ft Silicone Tubing, Metal Tubing Adapter, Glass Reservoir, Neoprene Stopper, Angled Tube Mounts, Foot	K974038	FDA 510(k)	Class II	Active
Sf Sh Catheter, Model R65-945	K013437	FDA 510(k)	Class II	Active
Rocket Electrode	K974138	FDA 510(k)	Class II	Active
Tacker, Model R65-933	K003949	FDA 510(k)	Class II	Active
Mini-Embryon Intra Uterine Insemination Catheter	K972823	FDA 510(k)	Class II	Active
Hsg Catheter Set, 5f Model Rgs0947, Hsg Catheter Set, 7f, Model R65-948	K013491	FDA 510(k)	Class II	Active
Rocket Mucus Sampler Syringe, Sterile, Rocket Mucus Sampler Syringe, Clinically Aspirator	K974032	FDA 510(k)	Class II	Active
Uritest 50 And Uritest 500 Urine Analyzer	K091472	FDA 510(k)	Class I	Active
Rocket Bone Marrow Needle	K895551	FDA 510(k)	Class I	Active
Rocket Sex Crime Kit	K883805	FDA 510(k)	Class I	Active
Suction Irrigation Trumpet Valve Set, Model Q65-823	K994256	FDA 510(k)	Class II	Active
Gynecologic Examination Kit	K894489	FDA 510(k)	Class II	Active
PyloPlus Urea Breath Test System	K052708	FDA PMA	Class III	Active

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