Question 1

What types of medical devices does Precision Biologic manufacture?

Accepted Answer

Precision Biologic specializes in in vitro diagnostic (IVD) products used in coagulation testing. Their portfolio includes reagents, controls, and clotting kits for assays like multiple coagulation factors, lupus anticoagulant markers, prothrombin time (PT), and activated partial thromboplastin time (APTT). These products are designed to help laboratories measure specific clotting factors (such as Factor VIII, IX, or XII) and detect lupus anticoagulant activity, aiding in the diagnosis of bleeding and clotting disorders.

Question 2

Where is Precision Biologic based, and what regulatory frameworks apply to its devices?

Accepted Answer

Precision Biologic is based in the United States. Their devices fall under FDA regulatory oversight, with classifications ranging from Class I to Class II. Many of their products are listed via the FDA’s 510(k) pathway and comply with Unique Device Identifier (UDI) requirements, ensuring traceability and regulatory compliance for in vitro diagnostics used in clinical settings.

Question 3

Which regulatory registries or databases list Precision Biologic’s devices?

Accepted Answer

Precision Biologic’s devices are listed in the FDA’s 510(k) premarket notification database and comply with UDI (Unique Device Identifier) requirements. These registries ensure transparency and traceability of their IVD products, which are intended for laboratory use in coagulation testing. The listings reflect individual device authorizations rather than company-wide approvals.

Question 4

How are Precision Biologic’s coagulation testing devices classified under regulatory standards?

Accepted Answer

Precision Biologic’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the complexity of its design, such as whether it involves clotting assays or reagent-based diagnostics.

Question 5

What is the primary purpose of Precision Biologic’s lupus anticoagulant marker products?

Accepted Answer

Precision Biologic’s lupus anticoagulant marker products, such as controls, reagents, and clotting kits, are designed to detect and evaluate lupus anticoagulant activity in patient samples. Lupus anticoagulants are antibodies that can interfere with coagulation tests, potentially leading to misdiagnosis of bleeding disorders. These products help laboratories accurately identify and monitor lupus anticoagulant presence, supporting precise diagnostic decisions for conditions like antiphospholipid syndrome.

Device	Model / Reference	Registries	Class	Status
CRYOcheck™ Lupus Positive Control	CCLP-10	FDA UDI	Class II	Active
CRYOcheck™ Factor XI Deficient Plasma	FDP11-15	FDA UDI	Class II	Active
CRYOcheck™ LA Check™	CHK-40	FDA UDI	Class I	Unknown
CRYOcheck™ Factor II Deficient Plasma	FDP02-10	FDA UDI	Class II	Active
CRYOcheck™ Factor VII Deficient Plasma	FDP07-10	FDA UDI	Class II	Active
CRYOcheck™ Factor XII Deficient Plasma	FDP12-15	FDA UDI	Class II	Active
CRYOcheck™ Low Fibrinogen Control	CCLF-10	FDA UDI	Class II	Active
Cryocheck Prekallikrein Deficient Plalsma, Model Fdpk10/10 (10 X 1.0 Ml), Fdpk10/25 (25 X 1.0ml)	K990296	FDA 510(k)	Class II	Active
Reference Check, Catalog Number-Rcn-10	K013708	FDA 510(k)	Class II	Active
Cryocheck La Sure, Model Sur25-10	K990580	FDA 510(k)	Class I	Active
Cryocheck Hex LA	K193556	FDA 510(k)	Class II	Active
Cryocheck Chromogenic Factor VIII	K193204	FDA 510(k)	Class II	Active
Chromocheck Protein C 25; Chromocheck Protein C 50	K023990	FDA 510(k)	Class II	Active
Cryocheck Weak Lupus Positive Control	K032804	FDA 510(k)	Class II	Active
Cryocheck La Check, Models Chk25-10 (25 X1.0 Ml), Chk80-10 (80 X 1.0 Ml)	K990579	FDA 510(k)	Class I	Active
Chromocheck Antithrombin 25; Chromocheck Antithrombin 50	K023991	FDA 510(k)	Class II	Active
Cryo Check Factor 2 Deficient Plasma, Models Fdpo2-10, Fdp02-15	K990814	FDA 510(k)	Class II	Active

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