(10 days)
Not Found
No
The description focuses on chemical reactions and optical monitoring, with no mention of AI/ML terms or processes.
No
The device is an in vitro diagnostic (IVD) system used to measure magnesium levels, which aids in diagnosis and treatment monitoring, but it does not directly treat or prevent a disease.
Yes
The "Intended Use / Indications for Use" section states that "Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia and hypermagnesemia," indicating a diagnostic purpose.
No
The device description clearly details a physical reagent disc designed to separate blood components and initiate chemical reactions, indicating it is a hardware component, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the in vitro quantitative determination of magnesium in heparinized whole blood, heparinized plasma, or serum". "In vitro" means "in glass" or "outside the body", which is a key characteristic of IVDs.
- Sample Type: The device analyzes biological samples (whole blood, plasma, or serum) taken from the body.
- Purpose: The measurements are used in the "diagnosis and treatment of hypomagnesemia and hypermagnesemia", which is a diagnostic purpose.
- Device Description: The description details how the device processes the biological sample and performs chemical reactions to obtain a result.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia and hypermagnesemia.
Product codes (comma separated list FDA assigned to the subject device)
JGJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratory setting or point-of-care location.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Brief discussion of the clinical and nonclinical tests relied on for a determination of substantial equivalence.
Linearty:
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.
Analyte: Magnesium (mg/dL)
Within-Run (n = 80):
Level 1 Mean: 1.9, SD: 0.03, CV: 1.7
Level 2 Mean: 3.9, SD: 0.04, CV: 1.0
Total (n = 80):
Level 1 Mean: 1.9, SD: 0.06, CV: 3.4
Level 2 Mean: 3.9, SD: 0.10, CV: 2.6
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 0.1 mg/dL
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 Road |
| Union 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 SE | ||
| Determination | |||
| Magnesium Slides on | |||
| the Vitros 950 | |||
| Chemistry System | Johnson and | ||
| Johnson Clinical | |||
| Diagnostics | 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
1
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-Care
Chemistry Analyzer | Vitros 950 Chemistry
System |
|-------------------------|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Quantitative analysis of
Magnesium | Quantitative analysis of
Magnesium |
| Methodology | Enzymatic rate reaction | Colorimetric |
| Sample Type | Heparinized whole blood,
heparinized plasma, and
serum | Heparinized plasma, serum, and
urine |
| Sensitivity | 0.1 mg/dL | 0.2 mg/dL |
| Reagents | Dry test-specific reagent
beads | Dry, multilayered, analytical element
coated 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 factory
calibrated lot specific data | Calibrated periodically using
calibrators 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
2
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 |
3
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.
4
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).
5
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
6
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 |
|---|---|
| -------- | --------- |