(59 days)
The Stat Profile Prime ES Comp Plus Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings for the quantitative determination of pH, Hematocrit, Ionized Calcium and Ionized Magnesium in heparinized venous whole blood, and pH. Ionized Calcium and Ionized Magnesium in plasma and serum.
Ionized Calcium (iCa) measurements are used in the diagnosis and treatment of parathyroid disease, a variety ofbone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Ionized Magnesium (iMg) measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium).
pH measurements are used in the diagnosis and treatment of life-threatening acid-base disturbances.
Hematocrit measurements of the packed red blood cell volume are used to distinguish normal from abnormal states, such as anemia and erythrocytosis.
The Stat Profile Prime ES Comp Plus Analyzer is a small, low cost blood electrolyte analyzer. 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 ES Comp Plus Analyzer has an enhanced test menu and multiple quality control options. External Control Solutions (ampules) shall be offered, as well as an on-board Quality Management System (QMS), an electronic monitoring approach that insures the analyzer is working properly.
The Stat Profile Prime ES Comp Plus Analyzer can accommodate either of two sensor cards in the sensor card housing. The analyzer will determine the test configuration of the system by detecting which sensor card is installed.
The two options for the sensor card are:
- Sensor Card 1 (Basic Electrolyte Panel plus Hct) shall enable and report the following listed analytes: Hct, Na, K, Cl
- Sensor Card 2(Full Electrolyte Panel plus pH & Hct) shall enable and report the following listed analytes: pH, Hct, Na, K, Cl, iCa, iMg
As with the predicates, the Stat Profile Prime ES Comp Plus Analyzer is microprocessor-based and incorporates ion selective electrode technology to measure pH, ionized calcium, ionized magnesium.
The Prime ES Comp Plus can be configured with an optional sample tray, which allows the user to run up to 10 consecutive samples may be any combination of Serum/Plasma or control solutions. Whole Blood samples may only be run in STAT Mode (not tray mode).
Calibration standards are provided in sealed pouches within a calibrator pack. Liquid quality control materials are available as external ampules. Sampling and calibration are fully automated.
The Stat Profile Prime ES Comp Plus Analyzer accepts lithium heparinized whole blood sample from syringes, open tubes, and small cups. The minimum sample sizes for analysis is 100 µL.
The provided text describes a 510(k) premarket notification for the "Stat Profile Prime ES Comp Plus Analyzer System," an in vitro diagnostic device for measuring various blood parameters. It does NOT describe an AI/ML-based device. Therefore, the requested information regarding AI/ML acceptance criteria, training/test sets, expert ground truth establishment, MRMC studies, etc., cannot be extracted from this document as it is not relevant to the described device.
The document focuses on demonstrating substantial equivalence to a predicate device (Nova Stat Profile pHOx Ultra Blood Gas Analyzer) through performance testing typically required for in vitro diagnostic devices, such as method comparison, precision, linearity, specificity/interference, detection limit, and shelf life stability.
Here's a breakdown of what can be extracted, addressing the closest relevant points, and explicitly stating what cannot be found:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria paired with the specific numerical reported device performance for each analyte (e.g., pH, iCa, iMg, Hct). Instead, it broadly states that "The results of the testing confirmed that the performance of the Stat Profile Prime ES Comp Plus Analyzer System is substantially equivalent to that of the Nova Stat Profile pHOx Ultra Blood Gas Analyzer (predicate device)." The study types performed are listed as:
- Method Comparison Studies
- Precision/Reproducibility Studies
- Run to Run Precision
- Linearity Testing
- Specificity / Interference Testing
- Detection Limit
- Shelf Life Stability Testing
Without the detailed test reports attached to this summary, the specific acceptance criteria thresholds and the measured performance values for each of these studies (e.g., specific bias ranges for method comparison, CV% limits for precision) are not available in this document.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the exact sample sizes used for each performance test (method comparison, precision, linearity, etc.).
- Data Provenance: Not explicitly stated, but clinical laboratory settings are mentioned for intended use, implying laboratory-conducted studies. No information on country of origin or whether the data was retrospective or prospective is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This question is not applicable. This device is an in vitro diagnostic analyzer, not an AI/ML system requiring human expert interpretation as ground truth for imaging or similar applications. The "ground truth" for the performance studies would be reference methods (for method comparison), known concentrations/values (for linearity/detection limit), or repeated measurements (for precision), all performed using established laboratory techniques, not expert consensus.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is not a human interpretation study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted diagnostic device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a standalone analytical device, but the term "standalone performance" in the context of your prompt usually refers to the accuracy of an AI algorithm on its own. For this device, all performance listed (method comparison, precision, etc.) is its standalone performance. The device operates without human-in-the-loop interpretation assistance, but rather as an automated analyzer whose results are then used by healthcare professionals.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" or reference values for this type of device would typically be:
- For Method Comparison: Results obtained from a well-established, validated reference method or another legally marketed device known for its accuracy.
- For Linearity: Samples with precisely known concentrations prepared gravimetrically or volumetrically.
- For Precision/Reproducibility: Statistical analysis of repeated measurements on stable samples.
The document does not specify the exact reference instruments or methods used, but this is the general approach for IVD devices.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a "training set." Its operating principles are based on ion-selective electrodes and impedance sensors, as described.
9. How the ground truth for the training set was established
Not applicable. See point 8.
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August 16, 2019
Nova Biomedical Corporation Cesidio Tempesta Regulatory Affairs Manager 200 Prospect St. Waltham, MA 02454
Re: K191626
Trade/Device Name: Stat Profile Prime ES Comp Plus Analyzer System Regulation Number: 21 CFR 862.1145 Regulation Name: Calcium test system Regulatory Class: Class II Product Code: JFP, CHL, CFA, GKF Dated: June 17, 2019 Received: June 18, 2019
Dear Cesidio Tempesta:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kellie B. Kelm, Ph.D. Acting Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191626
Device Name
Stat Profile Prime ES Comp Plus Analyzer System
Indications for Use (Describe)
The Stat Profile Prime ES Comp Plus Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings for the quantitative determination of pH, Hematocrit, Ionized Calcium and Ionized Magnesium in heparinized venous whole blood, and pH. Ionized Calcium and Ionized Magnesium in plasma and serum.
lonized Calcium (iCa) measurements are used in the diagnosis and treatment of parathyroid disease, a variety ofbone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
lonized Magnesium (iMg) measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium).
pH measurements are used in the diagnosis and treatment of life-threatening acid-base disturbances.
Hematocrit measurements of the packed red blood cell volume are used to distinguish normal from abnormal states, such as anemia and erythrocytosis.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| 510(K) Owner: | Nova Biomedical Corporation |
|---|---|
| Registration Number: | 1219029 |
| Address: | 200 Prospect St.Waltham, MA 02454 |
| Phone: | 781-894-0800 |
| Fax Number: | 784-891-4806 |
| Contact Person: | Cesidio Tempesta, Regulatory Affairs Manager |
| Date Prepared: | June 14, 2019 |
| 510k Number: | K191626 |
Proprietary Name: Stat Profile Prime ES Comp Plus Analyzer System
Common or Usual Name: Blood Gas/Electrolyte Analyzer
Classification Name: Multiple
| Classification Names: | Reg. No. | Class | Product Code | Panel |
|---|---|---|---|---|
| Calcium Test System | 862.1145 | II | JFP | Chemistry (75) |
| Magnesium Test System | 862.1495 | I, reserved | CFA | |
| Blood Gases and Blood pH system | 862.1120 | II | CHL | |
| Hematocrit Test System | 864.6400 | II | GKF | Hematology (81) |
Product Codes: CHL, JFP, CFA, GKF
Predicate Devices:
K110648 - Nova Stat Profile pHOx Ultra Blood Gas Analyzer
Device Description:
The Stat Profile Prime ES Comp Plus Analyzer is a small, low cost blood electrolyte analyzer. 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 ES Comp Plus Analyzer has an enhanced test menu and multiple quality control options. External Control Solutions (ampules) shall be offered, as well as an on-board Quality Management System (QMS), an electronic monitoring approach that insures the analyzer is working properly.
The Stat Profile Prime ES Comp Plus Analyzer can accommodate either of two sensor cards in the sensor card housing. The analyzer will determine the test configuration of the system by detecting which sensor card is installed.
The two options for the sensor card are:
- Sensor Card 1 (Basic Electrolyte Panel plus Hct) shall enable and report the following listed analytes: Hct, Na, K, Cl
- Sensor Card 2(Full Electrolyte Panel plus pH & Hct) shall enable and report the following listed analytes: pH, Hct, Na, K, Cl, iCa, iMg
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As with the predicates, the Stat Profile Prime ES Comp Plus Analyzer is microprocessor-based and incorporates ion selective electrode technology to measure pH, ionized calcium, ionized magnesium.
The Prime ES Comp Plus can be configured with an optional sample tray, which allows the user to run up to 10 consecutive samples may be any combination of Serum/Plasma or control solutions. Whole Blood samples may only be run in STAT Mode (not tray mode).
Calibration standards are provided in sealed pouches within a calibrator pack. Liquid quality control materials are available as external ampules. Sampling and calibration are fully automated.
The Stat Profile Prime ES Comp Plus Analyzer accepts lithium heparinized whole blood sample from syringes, open tubes, and small cups. The minimum sample sizes for analysis is 100 µL.
Measured Parameters:
The Stat Profile Prime ES Comp Plus Analyzer measures iCa, iMg, pH, and Hct,.
Calculated Parameters:
From the directly measured results, the following calculated results are available:
- Normalized Calcium, nCa ●
- Normalized Magnesium, nMq
- Ratio of nCa/nMg ●
- . Hb
- . pH (patient temperature corrected)
Intended Use:
The Stat Profile Prime ES Comp Plus Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings for the quantitative determination of pH, Hematocrit. Ionized Calcium and Ionized Magnesium in heparinized venous whole blood, and pH. Ionized Calcium and Ionized Magnesium in plasma and serum.
Indication for Use:
Ionized Calcium measurements are used in the diagnosis and treatment of parathyroid disease. a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Ionized Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium).
pH measurements are used in the diagnosis and treatment of life-threatening acid-base disturbances.
Hematocrit measurements of the packed red blood cell volume are used to distinguish normal from abnormal states, such as anemia and erythrocytosis.
Summary of the Technological Characteristics:
The Stat Profile Prime ES Comp Plus Analyzer is substantially equivalent to the previously cleared for market Nova Stat Profile pHOx Ultra Blood Gas Analyzer System in intended use. It uses the same sensor technology and measurement algorithms, and the formulations of the external controls and the calibration cartridge are the same for the tested parameters. The linearity standards and External Control solutions for use with the Stat Profile Prime ES Comp
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Plus Analyzer are substantially equivalent to those cleared for use with the predicate Nova Stat Profile pHOx Ultra Blood Gas Analyzer System (K110648).
| Characteristic | Predicate Stat Profile pHOx Ultra BloodGas Analyzer (K110648) | Proposed Stat Profile Prime ES CompPlus Analyzer |
|---|---|---|
| Indication For Use | The STP pHOx Ultra Analyzer withoutCO-Oximeter is intended for in vitrodiagnostic use by health careprofessionals and/or point-of-care usagein the quantitativedetermination of pH, PCO2, PO2, SO2%,Hematocrit (Hct), Hemoglobin (Hb) inheparinized whole blood; Na+, K+, Cl-,Ca++, Mg++, Glucose (Glu), Lactate(Lac), BUN (Urea), and Creatinine (Creat)in heparinized whole blood, serum, orplasma. | The Stat Profile Prime ES Comp PlusAnalyzer System is intended for in vitrodiagnostic use by health careprofessionals in clinical laboratorysettings for the quantitative determinationof pH, Hematocrit, Ionized Calcium andIonized Magnesium in heparinizedvenous whole blood, and pH, IonizedCalcium and Ionized Magnesium inplasma and serum. |
| Acceptable Samples | Sodium or lithium heparinized wholeblood, serum, or plasma samples fromsyringes, open tubes, small cups, andcapillary tubes can be used on the STPpHOx Ultra Analyzer. | Lithium heparin whole blood, serum andplasma samples from syringes, opentubes, and small cups |
| Sample Volumes | 60-210µL dependent on selected testpanel | 100µL |
| Measurement Range | ||
| iCa (Ca++) | 0.10 - 2.70 mmol/L | 0.20 - 2.70 mmol/L |
| iMg | 0.1 - 1.5 mmol/L | Same |
| pH | 6.500 - 8.000 | Same |
| Hematocrit | 12% - 70% | Same |
| Principles of Measurement | ||
| iCa (Ca++) | Calcium ion-selective sensor | Same |
| iMg | Magnesium ion-selective sensor | Same |
| pH | Hydrogen ion-selective glass sensor | Same |
| Hematocrit | Impedance Sensor | Same |
| Touch Screen | 12.1" LCD, 1024x768 pixel, ResistiveTouch | 5.7" VGA full color display with LEDbacklight and integrated touch panel |
| Menu | Fully configurable test menu based onabove sensors | Same |
| Bar Code Scanner | External (optional) 1D | Internal Integrated 1D/2D |
| Printer | 2" Roll, Thermal Transfer | Same |
| Pump | Peristaltic Pump w/ Pressure Plate, TPETubing (Pharmed BPT) | Same |
| Analog Board | Precision low level analog front end w/amperometric and potentiometricamplifiers, air detector circuitry andtemperature control circuitry | Same |
Table 2-1: Comparison of Predicate and Proposed devices
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Summary of Performance Testing:
Performance testing was completed to demonstrate that the Stat Profile Prime ES Comp Plus Analyzer is substantially equivalent in performance, safety and efficacy to the predicate Nova Stat Profile pHOx Ultra Blood Gas Analyzer (K110648).
The performance testing included:
- Method Comparison Studies .
- Precision/Reproducibility Studies .
- . Run to Run Precision
- Linearity Testing .
- . Specificity / Interference Testing
- . Detection Limit
- . Shelf Life Stability Testing
The results of the testing confirmed that the performance of the Stat Profile Prime ES Comp Plus Analyzer System is substantially equivalent to that of the Nova Stat Profile pHOx Ultra Blood Gas Analyzer (predicate device).
Conclusion:
The results of performance verification testing confirmed that the Stat Profile Prime ES Comp Plus Analyzer is safe and effective for its intended purpose and that the Stat Profile Prime ES Comp Plus Analyzer System is substantially equivalent to that of K110648 - Nova Stat Profile pHOx Ultra Blood Gas Analyzer (predicate device).
§ 862.1145 Calcium test system.
(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).(b)
Classification. Class II.