Stat Profile Prime Plus Analyzer System

K200349 · Nova Biomedical Corporation · CGA · Mar 13, 2020 · Clinical Chemistry

Device Facts

• Record ID: K200349
• Device Name: Stat Profile Prime Plus Analyzer System
• Applicant: Nova Biomedical Corporation
• Product Code: CGA · Clinical Chemistry
• Decision Date: Mar 13, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Indications for Use

The Stat Profile Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings and for point-of-care usage for quantitative determination of Glucose, Lactate, Creatinine, and Blood Urea Nitrogen in heparinized arterial and venous whole blood.

Device Story

Stat Profile Prime Plus Analyzer is a blood chemistry analyzer for hospital labs and point-of-care (POC) settings (e.g., ICU, ED). It accepts lithium heparinized arterial/venous whole blood (135 µL) via syringes or open tubes. The device uses interchangeable sensor cartridges (Primary/Auxiliary) to measure Glucose, Lactate, Creatinine, and BUN; it also calculates BUN/Creat ratio, Osmolality, and eGFR. Operation involves inserting samples; the analyzer performs automated enzymatic sensing. Results are displayed on a 10.1" touch screen and printed via an onboard thermal printer. The system includes an integrated Quality Management System (QMS) and electronic monitoring to ensure performance. Healthcare providers use these quantitative results to diagnose and monitor metabolic and renal conditions. The device benefits patients by providing rapid, accurate diagnostic data at the point of care, facilitating timely clinical decision-making.

Clinical Evidence

Performance verified via POC clinical study across 3 sites (CTICU, ED, RT) with 74 personnel. Method comparison (N=413-429) against lab methods showed high correlation (r=0.9975-0.9990). Precision studies (within-run and total imprecision) performed using QC materials and whole blood samples; results met accuracy goals (TE ≤ 0.3 for lactate). Bench testing included linearity (0.3-20.0 mmol/L for lactate), interference, and detection limit studies (LoB 0.0, LoD 0.1, LoQ 0.1 mmol/L).

Technological Characteristics

Benchtop analyzer with 10.1" WXGA touch screen, 1D/2D barcode scanner, and thermal printer. Uses enzymatic amperometric sensors (Glucose, Lactate, Creatinine) and potentiometric ion-selective electrode (BUN). Peristaltic pump with TPE tubing. Connectivity via integrated analog front end. Software manages configurable test menus and QMS. Sterilization not applicable (disposable cartridges).

Indications for Use

Indicated for healthcare professionals in clinical lab and point-of-care settings for quantitative measurement of Glucose (carbohydrate metabolism disturbances, diabetes, hypoglycemia), Lactate (acid-base status, lactic acidosis), Creatinine (renal conditions, dialysis monitoring), and BUN (renal/metabolic diseases) in heparinized arterial/venous whole blood.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) Number: k200349

This 510(k) was reviewed under OIR’s Triage-Quick Review Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.