(10 days)
The Piccolo Magnesium Test System (presently contained on the Renal Function Panel Plus Reagent Disc) used with the Piccolo Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of magnesium in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.
Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia and hypermagnesemia.
The Piccolo Renal Function Panel Plus Reagent Disc (which contains the Piccolo Magnesium Test System) is designed to separate a heparinized whole blood sample into plasma and blood cells. The disc meters the required quantity of plasma and diluent, mixes the plasma with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted plasma mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer. Alternately, the disc may also be used with serum.
The provided document describes the safety and effectiveness of the Piccolo® Magnesium Test System. The device is intended for the in vitro quantitative determination of magnesium in heparinized whole blood, heparinized plasma, or serum.
Here's an analysis of the acceptance criteria and the study performance:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" with pass/fail thresholds for each metric. Instead, it presents performance data (linearity, precision) and draws a conclusion of substantial equivalence to a predicate device. For the purpose of this analysis, we will infer the "acceptance criteria" through comparison to the predicate device's characteristics and general expectations for clinical laboratory devices.
| Performance Metric | Predicate Device (Vitros 950 Magnesium Slides) | Piccolo Magnesium Test System Reported Performance | Implied Acceptance Criteria (Based on Substantial Equivalence) | Met? |
|---|---|---|---|---|
| Linearity | Not explicitly stated (implied to be acceptable) | Slope: 0.992, Intercept: -0.05, Corr. Coefficient: 0.999 | Correlation Coefficient ≥ 0.99 (or comparable to predicate) | Yes |
| Sensitivity | 0.2 mg/dL | 0.1 mg/dL | Equal to or better than predicate (≤ 0.2 mg/dL) | Yes |
| Assay Range | 0.2 - 10.0 mg/dL | 0.1 - 8.0 mg/dL | Comparable to predicate's clinical relevance Range | Yes* |
| Within-Run Precision (CV) | Not explicitly stated | Level 1: 1.7%, Level 2: 1.0% | CVs typically < 5% or comparable to predicate | Yes |
| Total Precision (CV) | Not explicitly stated | Level 1: 3.4%, Level 2: 2.6% | CVs typically < 5% or comparable to predicate | Yes |
| Sample Type Comparability | Heparinized plasma, serum, urine | Heparinized venous whole blood, serum | Demonstrated comparability for declared sample types | Yes |
*Note on Assay Range: While the Piccolo's upper range (8.0 mg/dL) is slightly lower than the predicate (10.0 mg/dL), the lower range is better (0.1 mg/dL vs 0.2 mg/dL). The document concludes that these values support substantial equivalence, implying the clinical utility of the 0.1 - 8.0 mg/dL range is acceptable.
2. Sample Size Used for the Test Set and Data Provenance:
- Linearity Study: Sample sizes are not explicitly stated, but are generally multi-point dilutions across the assay range.
- Precision Study:
- Within-Run and Total Precision: "n=80" for each level (Level 1 and Level 2) for Magnesium. This 'n' likely refers to the number of replicates performed to achieve the precision data.
- Sample Type Comparison: Sample sizes are not explicitly stated.
- Data Provenance: The document does not specify the country of origin of the data. The studies appear to be prospective as they were specifically performed to evaluate the performance of the Piccolo Magnesium Test System.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not provided in the document. For in vitro diagnostic devices like the Piccolo Magnesium Test System, "ground truth" is typically established by reference methods or comparison to established, legally marketed devices. The document references the Vitros 950 Chemistry System as the predicate device, implying its performance serves as a comparative "ground truth" or benchmark.
4. Adjudication Method for the Test Set:
This information is not applicable and therefore not provided. Adjudication methods (e.g., 2+1) are typically used in clinical trials where human interpretation or expert consensus is required to establish a diagnosis, especially in imaging studies. For a quantitative chemical analyzer, the "truth" is derived from the analytical performance (e.g., linearity, precision, accuracy against a reference method or validated predicate).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for evaluating the impact of AI or new technologies on human reader performance, often in diagnostic imaging. The Piccolo Magnesium Test System is a standalone analytical device, not an AI-assisted interpretation tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, a standalone performance study was done. The entire document focuses on the analytical performance of the Piccolo Magnesium Test System as a standalone device (algorithm only, in the sense of the instrument's processing logic), without human-in-the-loop performance as it relates to diagnostic interpretation. The studies on linearity, precision, and sample type comparability are all standalone performance assessments.
7. The Type of Ground Truth Used:
The primary "ground truth" used for comparison appears to be the performance characteristics of a legally marketed predicate device (Vitros 950 Chemistry System - Magnesium Slides) and established analytical chemistry principles. While not explicitly stated, the linearity and precision studies would have used control materials or patient samples with known or well-characterized magnesium concentrations, which act as the ground truth for those measurements. The "gold standard" for magnesium measurement itself is a well-defined chemical assay.
8. The Sample Size for the Training Set:
This information is not applicable and therefore not provided. The Piccolo Magnesium Test System is a traditional in vitro diagnostic device, not an AI/ML device that requires a distinct "training set" in the computational learning sense. The device's factory calibration and lot-specific data, referenced in the calibration method, suggest internal validation and calibration processes, but not a "training set" like that used for algorithms.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the reasons stated above (not an AI/ML device). The "ground truth" for its calibration would be based on certified reference materials and established metrological traceability for magnesium concentrations.
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JAN 5 0 2004
onle Road, Union City, CA 94587 510 . 675-6500 Fax 510 . 441-6150
ABAXIS
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K040115
1. Applicant Information:
| Date Prepared: | January 15, 2004 |
|---|---|
| Name: | Abaxis, Inc. |
| Address: | 3240 Whipple RoadUnion City, CA 94587 |
| Contact Person: | Dennis M. Bleile, PhD |
| Phone Number: | (510) 675-6515 |
2. Device Information:
Fax Number:
| Classification | Class I |
|---|---|
| Trade Name: | Piccolo® Magnesium Test System |
(510) 441-6150
862.1495 Classification Name: Magnesium Test system
Identification of legally marketed device to which the submitter claims 3. equivalence:
The following table identifies the legally marketed device to which Abaxis claims equivalence:
| Predicate Device | |||
|---|---|---|---|
| Predicate Device | Manufacturer | 510(k)Number | Date of SEDetermination |
| Magnesium Slides onthe Vitros 950Chemistry System | Johnson andJohnson ClinicalDiagnostics | K861386 | 8/26/86 |
4. Description of the Device:
The Piccolo Renal Function Panel Plus Reagent Disc (which contains the Piccolo Magnesium Test System) is designed to separate a heparinized whole blood sample into plasma and blood cells. The disc meters the required quantity of plasma and
1
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Summary of Safety and Effectiveness (continued)
diluent, mixes the plasma with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted plasma mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer. Alternately, the disc may also be used with serum.
Statement of Intended Use: 5.
The Piccolo Magnesium Test System (presently contained on the Renal Function Panel Plus Reagent Disc) used with the Piccolo Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of magnesium in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.
Summary of the technological characteristics of the new device in comparison 6. to those of the predicate device:
Table 1 outlines the technological characteristics of the Piccolo Magnesium Test System in comparison to the legally marketed predicate device.
| Piccolo Point-of-CareChemistry Analyzer | Vitros 950 ChemistrySystem | |
|---|---|---|
| Intended Use | Quantitative analysis ofMagnesium | Quantitative analysis ofMagnesium |
| Methodology | Enzymatic rate reaction | Colorimetric |
| Sample Type | Heparinized whole blood,heparinized plasma, andserum | Heparinized plasma, serum, andurine |
| Sensitivity | 0.1 mg/dL | 0.2 mg/dL |
| Reagents | Dry test-specific reagentbeads | Dry, multilayered, analytical elementcoated on a polyester support (slide).Active ingredients: 1,2-bis(o-aminophenoxy)ethane-N,N,N', N'-tetraacetic acid (calcium chelator)and 1,5-bis(2-hydroxy-3,5-dichlorophenyl)-3-cyano-formazan(dye) |
| Temperature of Reaction | 37°C | 37°C |
| Calibration | Bar code with factorycalibrated lot specific data | Calibrated periodically usingcalibrators supplied by vendor |
| Assay Range | 0.1 - 8.0 mg/dL | 0.2 - 10.0 mg/dL |
| Testing Environment | Professional use | Professional use |
| Sample Size | Approximately 100 µL | 10 µL |
Table 1: Specification Comparison: Piccolo Magnesium Test System
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Summary of Safety and Effectiveness (continued)
Brief discussion of the clinical and nonclinical tests relied on for a 7. determination of substantial equivalence.
Tables 2 summarize the results of clinical and non-clinical tests performed using the Piccolo Magnesium Test System.
Linearity:
Table 2: Summary of Linearity
| Magnesium | ||
|---|---|---|
| Slope | 0.992 | |
| Intercept | -0.05 | |
| Corr. Coefficient | 0.999 |
Precision:
Precision studies were designed to evaluate within-run and total precision of the Magnesium Test System when run on the Piccolo Point-of-Care Chemistry Analyzer.
Table 3: Within-Run and Total Precision for Magnesium, Assayed on the Piccolo Point-of-Care Chemistry Analyzer
| Analyte | Within-Run (n = 80) | Total (n = 80) |
|---|---|---|
| Magnesium (mg/dL) | ||
| Level 1 | ||
| Mean | 1.9 | 1.9 |
| SD | 0.03 | 0.06 |
| CV | 1.7 | 3.4 |
| Level 2 | ||
| Mean | 3.9 | 3.9 |
| SD | 0.04 | 0.10 |
| CV | 1.0 | 2.6 |
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Summary of Safety and Effectiveness (continued)
Sample Type Comparison:
A study was conducted to examine and compare heparinized venous whole blood and serum on the Piccolo® Point-of-Care Chemistry Analyzer.
Serum, heparinized plasma and heparinized whole blood comparability were established for magnesium.
8. Conclusions
The clinical and non-clinical tests performed for Magnesium, when run on the Piccolo Point-of-Care Chemistry Analyzer demonstrate that the test system is as safe, effective and performs as well as the legally marketed device identified above.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the graphic.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 5 0 2004
Dennis M. Bleile, Ph.D. Director of Assay Development Abaxis, Inc. 3240 Whipple Road Union City. CA 94587
K040115 Re:
Trade/Device Name: Piccolo® Magnesium Test System Regulation Number: 21 CFR 862.1495 Regulation Name: Magnesium test system Regulatory Class: Class I Product Code: JGJ Dated: January 15, 2004 Received: January 20, 2004
Dear Dr. Bleile:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 r least be as made a determination that your device complies with other requirements of the Act that 1197 for a lotations and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper, MS, DVM.
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT 12.0
Indications for Use
510(k) Number (if known): KnHz 0 )// 5
Piccolo® Magnesium Test System Device Name:
Intended Use:
The Piccolo Magnesium Test System (presently contained on the Renal Function Panel Plus Reagent Disc) used with the Piccolo Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of magnesium in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.
Indications for Use:
Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia and hypermagnesemia.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | OR | Over- The Counter Use (Optional Format 1-2-96) |
|---|---|---|
| --------------------------------------- | ---- | ------------------------------------------------ |
| Division Sign-Off | Carol Benson for Jean Cooper, DVM |
|---|---|
| ------------------- | ------------------------------------------------- |
Office of In Vitro Diagnostic Device Evaluation and Safety
| 510(k) | K040115 |
|---|---|
| -------- | --------- |
§ 862.1495 Magnesium test system.
(a)
Identification. A magnesium test system is a device intended to measure magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).(b)
Classification. Class I.