(30 days)
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.
Glucose measurement is used in the diagnosis and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Lactate (lactic acid) measurement is used to evaluate the acid-base status of patients suspected of having lactic acidosis.
Creatinine measurement is used in the diagnosis and treatment of certain renal conditions and for monitoring adequacy of dialysis.
Blood Urea Nitrogen measurement is used in the diagnosis and treatment of certain renal and metabolic diseases.
The Stat Profile Prime Plus Analyzer System is a low cost, low maintenance analyzer for hospital laboratory and point-of-care settings. It consists of the analyzer, sensor cartridges, and thermal paper for an onboard printer. Optionally, it provides for reading of barcode labels (such as operator badges and data sheets).
The Stat Profile Prime Plus Analyzer has slots to accommodate two sensor cartridges (Primary and Auxiliary). The analyzer will determine the configuration of the system by detecting which sensor cards are installed.
Primary Sensor Card Port:
There are two options for the primary sensor card:
- Primary Sensor Card 1 shall enable and report the following listed analytes: o Glu. Lactate
- Primary Sensor Card 2 shall enable and report the following listed analytes: o Glu, Lactate
Auxiliary Sensor Card Port:
The reporting of Creatinine and BUN parameters (or not reporting them) shall be determined by the selection of the Auxiliary Sensor Card
- Auxiliary Sensor Card 1 shall enable Creatinine and BUN parameters .
- . Auxiliary Sensor Card 2 shall be a "dummy" sensor card, and will not report any parameters.
As with the predicate, the Stat Profile Prime Plus Analyzer is a blood gas, co-oximetry, electrolyte, chemistry, and hematology analyzer with an enhanced test menu and multiple quality control options. Both traditional internal and external quality control is available, as well as an on-board Quality Management System (QMS), and an electronic monitoring approach that insures the analyzer is working properly at all times.
The Stat Profile Prime Plus Analyzer accepts samples from syringes and open tubes. The minimum sample size for analysis is 135 µL.
Sample collection, preparation and application to the analyzer are the same as for the previously cleared predicate. The end user can select which analytes are to be tested in the panel.
Stat Profile Prime Plus Analyzer System Components:
The Stat Profile Prime Plus Analyzer System is comprised of the following components.
- Stat Profile Prime Plus Analyzer System .
- Primary Sensor Cartridge .
- Auxiliary Sensor Cartridge
- Stat Profile Prime Plus Auto-Cartridge Quality Control Pack ●
- Stat Profile Prime Plus Calibrator Cartridge ●
- Stat Profile Prime Plus External Ampuled Control .
- . IFU/Labeling
This document describes the performance of the Stat Profile Prime Plus Analyzer System for the quantitative determination of Glucose, Lactate, Creatinine, and Blood Urea Nitrogen in heparinized arterial and venous whole blood. The submission specifically focuses on the modification of the device to include Point-of-Care (POC) use.
It is important to note that this document is a 510(k) summary for a medical device. This type of document typically focuses on demonstrating substantial equivalence to a previously cleared device, rather than proving novel clinical effectiveness with large-scale comparative effectiveness studies. Therefore, not all requested sections directly apply, especially those related to AI model development (training set, human-in-the-loop, MRMC studies) common in submissions for AI/ML-based diagnostic software. This device is a point-of-care blood analyzer, not an AI diagnostic software.
Here's the breakdown of the provided information within the context of this device:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present explicit "acceptance criteria" in a singular table for all parameters as one might find for a pass/fail threshold in an AI/ML study. Instead, performance is demonstrated through various analytical validation studies (precision, linearity, interference, detection limit) and a method comparison study to show equivalence to a predicate device and laboratory methods. The "acceptance criteria" are implicitly met if the performance data supports substantial equivalence for the intended use and accuracy compared to established methods.
For Lactate (specifically detailed in the provided text):
| Performance Metric | Implicit Acceptance Criteria (based on context of equivalence) | Reported Device Performance (Lactate) |
|---|---|---|
| Precision/Reproducibility | Demonstrates acceptable within-run and run-to-run variability across different sample types and levels. | - Within-Run (Auto QC Cartridge Levels 4 & 5): CV% ranged from 0.00% to 0.68%. |
- Within-Run (Quality Control Ampules Levels 4 & 5): CV% ranged from 0.00% to 1.6%.
- Within-Run (Whole Blood from Syringes, 5 samples): CV% ranged from 1.3% to 8.0%.
- Run-to-Run (Auto QC Cartridge Levels 4 & 5): Total Imprecision %CV ranged from 1.4% to 3.5%.
- Run-to-Run (Whole Blood, 5 samples): CV% ranged from 1.8% to 14.7%. Note: Blood #1 showed a higher CV of 13.3-14.7% across devices. |
| Linearity | Demonstrates linearity across the claimed measurement range, with a high correlation (r-value) to established methods. | - Claimed Measurement Range: 0.3 - 20.0 mmol/L. - Specimen Range Tested: 0.2 - 23.5 mmol/L.
- Analyzers (PP1, PP2, PP3): r-values were 0.9983, 0.9982, and 0.9988, respectively.
- Comment: Results support the claimed measurement range. |
| Specificity / Interference | Identifies substances that may interfere and quantifies the highest concentration tested that shows no significant interference. | - Dose response study performed for glycolic acid and hydroxyurea showed interference at all concentrations. (Specific concentrations not given, but the fact of interference is noted). - Table 7 lists the highest non-interfering concentrations for 23 other common substances (e.g., Acetaminophen, Ascorbic Acid, Bilirubin, Ethanol, Heparin, Ibuprofen). |
| Detection Limit (LoB, LoD, LoQ) | LoB, LoD, and LoQ should be below the lower limit of the claimed measurement range. | - LoB: 0.0 mmol/L - LoD: 0.1 mmol/L
- LoQ: 0.1 mmol/L.
- Comment: All are below the claimed lower limit of 0.3 mmol/L. |
| Method Comparison (POC vs. Lab) | Statistical agreement between the Stat Profile Prime Plus system (operated at POC by various personnel) and laboratory reference methods (implicitly, lab instruments or methodologies used for comparison). | - Analyte: Lactate - N: 413 samples
- Range: 0.5 - 16.5
- Slope: 1.0181
- Intercept: -0.0796
- r (correlation coefficient): 0.9975
- 95% Confidence Interval Bias (2 mmol/L): 1.9-2.0
- 95% Confidence Interval Bias (6 mmol/L): 6.0-6.1 |
| Total Imprecision Performance (POC)| Demonstrates acceptable total imprecision when operated by POC personnel. | - Lactate (Level 4): Mean 1.8 mmol/L, Total SD 0.1, Total %CV 3.2% - Lactate (Level 5): Mean 6.7 mmol/L, Total SD 0.2, Total %CV 3.4%
- Lactate (Linearity Level 4): Mean 16.5 mmol/L, Total SD 0.4, Total %CV 2.2% |
| Within-Run Whole Blood Precision (POC)| Demonstrates acceptable within-run precision for fresh whole blood samples in POC setting. | - Lactate (7 samples): Mean values varied (e.g., 3.30, 1.43, 2.47, 2.49, 1.24, 4.69, 11.4 mmol/L). Reported %CVs ranged from 4.08% to 6.68%. |
2. Sample Sizes Used for the Test Set and Data Provenance
The "test set" in this context refers to the samples used in the analytical performance and method comparison studies.
-
Sample Sizes:
- Lactate Precision (Within-Run): 20 replicates for each level/sample type (QC, Ampules, Whole Blood) on 3 analyzers.
- Lactate Precision (Run-to-Run): QC samples: 240 samples (2 runs/day for 40 runs * 3 analyzers); Whole Blood samples: 30 samples (triplicate analyses over 10 runs * 3 analyzers).
- Linearity: 9 levels tested on 3 analyzers.
- Interference: Not explicitly stated for each substance, but dose-response performed for problematic interferents.
- Detection Limit: LoB: 5 runs on 2 analyzers; LoD: 4 runs on 2 analyzers for 5 low-level samples over 3 days (total 60 replicates per reagent lot); LoQ: 3 runs on 2 analyzers for 4 low-level samples over 3 days (total 36 replicates per reagent lot).
- Method Comparison (POC vs. Lab): For Lactate: N=413 samples.
- Total Imprecision (POC): 3 levels of QC/Linearity materials, run in duplicate each day for 20 runs on 3 analyzers.
- Within-Run Whole Blood Precision (POC): 10 replicate measurements for 7 different whole blood samples at each site, by a minimum of 2 POC operators at 3 sites (total 9 operators).
-
Data Provenance:
- Country of Origin: Not explicitly stated but inferred to be the United States (given the FDA submission and the company address in Waltham, Massachusetts).
- Retrospective or Prospective: The studies described (e.g., precision, linearity, method comparison) are typically prospective analytical validation studies conducted specifically for regulatory submission, using controlled conditions and fresh/altered samples collected for the purpose of the study. The POC study involved current operations ("discarded blood gas specimens" and "fresh, native and altered whole blood samples") and training of personnel for the study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
For this type of in vitro diagnostic device (blood analyzer), "ground truth" is established by comparison to reference methods or calibrated standards rather than expert consensus on images.
- Number of Experts: Not applicable in the context of expert readers for imaging or clinical diagnosis. The "experts" are the laboratory personnel operating the reference instruments and the Point-of-Care personnel who were "trained, qualified staff found in typical POC sites where blood gas analyzers are utilized."
- Qualifications of Experts:
- Laboratory Personnel: Implied to be qualified professionals operating the reference analyzers (e.g., Stat Profile pHOx Ultra Analyzer System, K110648).
- Point-of-Care Personnel: A total of 61 Respiratory Care, 12 Nursing, and 1 Exercise Physiology personnel participated from 3 POC settings (Cardiothoracic Intensive Care Unit (CTICU), Emergency Department (ED), Respiratory Therapy Lab (RT)). They are described as "trained, qualified staff."
4. Adjudication Method for the Test Set
Not applicable. This is not an AI/ML diagnostic software involving subjective interpretation or multiple expert reads needing adjudication. Performance is assessed analytically against reference methods or statistical metrics.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not conducted. This type of study is primarily relevant for AI/ML-based diagnostic software where the AI assists human readers in tasks like image interpretation. This submission is for an in vitro diagnostic device that directly measures analytes in blood. The study compared the device's performance to predicate devices and laboratory methods.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the device's measurement process for each analyte (e.g., impedance, amperometry) can be considered "standalone" in that it performs the measurement algorithmically, the term "standalone performance" in the context of AI/ML usually refers to the accuracy of the algorithm without any human input during the diagnostic process.
For this device, the "measurements" are the direct outputs from the instrument. Its analytical performance (precision, linearity, detection limits, interference) is evaluated intrinsically (standalone from a human operator's interpretation, though a human initiates the test). The "Method Comparison Studies" then compare these outputs to a reference method, which is the closest equivalent to a "standalone" performance assessment for an IVD, demonstrating how well the device matches established lab results.
7. The Type of Ground Truth Used
The ground truth for this device's performance validation is based on reference methods and calibrated standards.
- Reference Methods: The "Method Comparison Studies" compare the Stat Profile Prime Plus Analyzer System's results (both in the lab and at POC) to those obtained from the predicate device (K180340) and/or other validated laboratory methods/instruments. For Lactate, the predicate K110648 (Stat Profile pHOx Ultra Analyzer System) was used for comparison.
- Calibrated Standards: Precision, linearity, and detection limit studies utilize quality control materials, calibrators, and prepared solutions with known concentrations. The linearity study specifically states comparison to "the reference analyzer and/or the product specifications defined in the Stat Profile Prime Marketing Requirements document."
8. The Sample Size for the Training Set
Not applicable. This device is an in vitro diagnostic analyzer (hardware and embedded software for physical measurement), not an AI/ML algorithm that is "trained" on a dataset in the conventional sense. The "development" of its analytical components involves traditional engineering and chemistry, not machine learning training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of AI/ML for this device. The physical and chemical principles of measurement (e.g., enzymatic reactions, amperometry, potentiometry) form the basis of the device's function.
§ 862.1345 Glucose test system.
(a)
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.(b)
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.