(31 days)
Not Found
No
The summary describes a standard in vitro diagnostic device that performs chemical analysis. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
This device is an in vitro diagnostic (IVD) device used for the quantitative determination of sodium levels, which aids in diagnosis and treatment, but it does not directly treat or prevent a disease or condition itself.
Yes
The device is intended for the in vitro quantitative determination of sodium, and sodium measurements are used in the diagnosis and treatment of various conditions. This directly aligns with the definition of a diagnostic device.
No
The device description clearly states it is a "Test System (contained on the Piccolo MetLyte 7 Reagent Disc)" and describes physical components like a disc, plasma separation, metering, mixing, and reagent beads, indicating it is a hardware-based system with chemical reactions, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "in vitro quantitative determination of sodium 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 human body.
- Purpose: The sodium measurements are used "in the diagnosis and treatment of dehydration, diabetes insipidus, loss of hypotonic gastrointestinal fluids, sait poisoning, selective depression of sense of thirst, skin losses, burns, sweating, hyperaldosteronism, CNS disorders, dilutional, depletional and delusional hyponatremia and syndrome of inappropriate ADH secretion." This clearly indicates a medical purpose related to diagnosis and treatment, which is the core function of IVDs.
- Device Description: The description details how the device processes the biological sample to perform chemical reactions for analysis.
- Performance Studies: The document includes performance studies (Linearity, Precision, Sample Type Comparison) which are standard for demonstrating the analytical performance of an IVD.
- Key Metrics: Metrics like Sensitivity, Accuracy, Linearity, and Precision are reported, which are relevant to the performance evaluation of an IVD.
- Predicate Device: A predicate device (Radiometer America, Inc. KNA™ 2 Sodium-Potassium Analyzer) is listed, which is a common practice for demonstrating substantial equivalence for IVD submissions to regulatory bodies.
All of these factors strongly indicate that the Piccolo Sodium Test System is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Piccolo® MetLyte 7 Reagent Disc (contains Piccolo Sodium Test System) used with the Piccolo Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of sodium in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.
The sodium assay is used for the quantitation of sodium in human heparinized whole blood, heparinized plasma, or serum. Sodium measurements are used in the diagnosis and treatment of dehydration, diabetes insipidus, loss of hypotonic gastrointestinal fluids, sait poisoning, selective depression of sense of thirst, skin losses, burns, sweating, hyperaldosteronism, CNS disorders, dilutional, depletional and delusional hyponatremia and syndrome of inappropriate ADH secretion.
Product codes
JGS
Device Description
The Piccolo Sodium Test System (contained on the Piccolo MetLyte 7 Reagent Disc) is designed to separate a heparinized whole blood sample into plasma and blood cells. The disc also meters the required quantity of plasma and diluent, mixes 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: Linearity
Sample Size: Not specified
Key Results: Data for sodium were found to be statistically linear at the 99% significance level by the Ftest.
F-Ratio: 0.99
Slope: 0.99
Intercept: -1.00
Corr. Coefficient: 1.00
Study Type: Precision (Within-Run and Total)
Sample Size: n = 80 (Results pooled from 4 instruments, each running 20 discs)
Test Material: Moni-Trol 1, Moni-Trol 2
Key Results:
Moni-Trol 1:
Within-Run Mean: 144, SD: 2.3, CV: 1.6
Total Mean: 144, SD: 2.3, CV: 1.6
Moni-Trol 2:
Within-Run Mean: 120, SD: 2.1, CV: 1.8
Total Mean: 120, SD: 2.1, CV: 1.8
Study Type: Sample Type Comparison (Venous whole blood and serum)
Key Results: Serum and whole blood comparability were established for sodium.
Key Metrics
Accuracy:
Sample size (n): 113
Corr. Coefficient: 0.937
Slope: 0.782
Intercept: 27.70
SEE: 3.79
R-Square: 0.878
Sensitivity: 2.8 (A mA/min)/(mmol/L) (for Piccolo Point-of-Care Chemistry Analyzer)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1665 Sodium test system.
(a)
Identification. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.(b)
Classification. Class II.
0
Summary of Safety and Effectiveness, Page 4
Sample Type Comparison:
A study was conducted to compare venous whole blood and serum run on the Piccolo® Point-of-Care Chemistry Analyzer.
Serum and whole blood comparability were established for sodium.
8. Conclusions
The clinical and non-clinical tests performed using the Piccolo Sodium Test System (contained on the Piccolo MetLyte 7 Reagent Disc) demonstrate that the device is as safe, effective and performs as well as the legally marketed predicate device identified above.
1
OCT 25 599
1320 Chesapeake Terrace, Sunnyvale, CA 84089
Phone 408 • 734-0200 Fax 408 • 734-2874
Image /page/1/Picture/2 description: The image shows the word "ABAXIS" in a stylized font. The letters are in black and are bold. A black oval shape surrounds the letters "XIS" in the word. The font is sans-serif and appears to be a logo.
This 510(k) summary of safety and effectiveness information is being submitted in
tell and experience of the COMDA 4000 and 21 CER 807 92 This 510(K) summary of salety and Chocaveness .
accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K993211
Applicant Information: 1.
| Date Prepared: | September 23, 1999 |
|---|---|
| Name: | Abaxis, Inc. |
| Address: | 1320 Chesapeake Drive |
| Sunnyvale, CA 94089 |
| Contact Person: | Lisa G. McGrath |
|---|---|
| Phone Number: | (408) 745-6880 |
| Fax Number: | (408) 734-2874 |
Device Information: 2.
| Classification | Class II |
|---|---|
| Trade Name: | Piccolo® Sodium Test System |
Classification Name:
Sodium test system 862.1665
ldentification of legally marketed device to which the submitter claims 3. equivalence:
The following table identifies the legally marketed device to which Abaxis claims equivalence:
| : 24 8 2 3 0 ( 2002 16) : 1 ( 1 ( 1 ) ( 1 ) ( 1 ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) | 11:1011117 10:44 r : 5 - | 1131 - 101 - 14 | 1718: 0) - 295
. 1728 : } : 38 : 18 : 3 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| KNA™ 2 Sodium-
Potassium Analyzer | Radiometer
America, Inc. | K830805 | 4/8/83 |
Description of the Device: 4.
The Piccolo Sodium Test System (contained on the Piccolo MetLyte 7 Reagent Disc) is designed to separate a heparinized whole blood sample into plasma and Disc) is designed to beparate a neguired quantity of plasma and diluent, mixes the discus blood cells. The diso meters the mixture to the reaction cuvettes along the disc
2
Summary of Safety and Effectiveness, Page 2
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.
5. Statement of Intended Use:
The Piccolo® MetLyte 7 Reagent Disc (contains Piccolo Sodium Test System) used with the Piccolo Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of sodium in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.
6. Summary of the technological characteristics of the new device in comparison to those of the predicate device:
Table 1 outlines the technological characteristics of the Piccolo Sodium Test System in comparison to the legally marketed predicate device.
| | Piccolo Point-of-Care
Chemistry Analyzer | Radiometer KNA™ 2 Sodium
Potassium Analyzer |
|-------------------|--------------------------------------------------|--------------------------------------------------------------------------------------|
| Intended Use | quantitative analysis of
sodium | quantitative determination of
sodium |
| Methodology | enzymatic activation | ion-selective electrodes |
| Sample Type | whole blood, plasma,
serum | whole blood, plasma,
serum, urine |
| Sensitivity | 2.8 (A mA/min)/(mmol/L) | 3.1 (mmol/L)/(mV) |
| Reagents | dry, test specific reagent beads | N/A |
| Temperature | 37°C | 37° C |
| Calibration | bar code with disc-
specific calibration data | automatic 1 point calibration
every 2 hours; 2 point
calibration every 8 hours |
| Assay Range | 110 - 170 mmol/L | 7 - 350 mmol/L |
| Accuracy: | | |
| Sample size (n) | 113 | |
| Corr. Coefficient | 0.937 | |
| Slope | 0.782 | |
| Intercept | 27.70 | |
| SEE | 3.79 | |
| R-Square | 0.878 | |
Table 1 : Specification Comparison: Piccolo Sodium Test System
3
Summary of Safety and Effectiveness, Page 3
Brief discussion of the clinical and nonclinical tests relied on for a 7. determination of substantial equivalence.
Table 2 summarizes the results of clinical and non-clinical tests performed using the Piccolo® Sodium Test System.
Linearity:
Data for sodium were found to be statistically linear at the 99% significance level by the Ftest.
| Table 2 | |
|---|---|
| Summary of Linearity | |
| Sodium | |
| F-Ratio | 0.99 |
| Slope | 0.99 |
| Intercept | -1.00 |
| Corr. Coefficient | 1.00 |
99% Critical F 2.99
Precision:
Precision studies were designed to evaluate within-run and total precision of sodium included on the Piccolo MetLyte 7 Reagent Disc when run on the Piccolo Point-of-Care Chemistry Analyzer.
| Table 3:
Within-Run and Total Precision of Sodium Run
| on the Piccolo Point-of-Care Chemistry AnalyzerA | ||
|---|---|---|
| Within-Run | ||
| (n = 80) | Total | |
| (n= 80) | ||
| Moni-Trol 1 | ||
| Mean | 144 | 144 |
| SD | 2.3 | 2.3 |
| CV | 1.6 | 1.6 |
| Moni-Trol 2 | ||
| Mean | 120 | 120 |
| SD | 2.1 | 2.1 |
| CV | 1.8 | 1.8 |
A Results pooled from 4 instruments each running 20 discs.
4
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird with three wing-like shapes, representing the department's mission to protect the health of all Americans and provide essential human services.
OCT 2 5 1999
Ms. Lisa G. McGrath Regulatory Affairs Specialist Abaxis 1320 Chesapeake Terrace Sunnyvale, California 94089
Re: K993211
Trade Name: Piccolo® Sodium Test System Regulatory Class: II Product Code: JGS Dated: September 23, 1999 Received: September 24, 1999
Dear Ms. McGrath:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
5
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Steven Putman
Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
| Indications for Use | ||
|---|---|---|
| 510(k) Number (if known): | K993211 |
Piccolo® Sodium Test System Device Name:
Intended Use:
The Piccolo Sodium Test System (contained on the MetLyte 7 Reagent Disc), used with the Piccolo Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of sodium in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.
Indications for Use:
The sodium assay is used for the quantitation of sodium in human heparinized whole blood, heparinized plasma, or serum. Sodium measurements are used in the diagnosis and treatment of dehydration, diabetes insipidus, loss of hypotonic gastrointestinal fluids, sait poisoning, selective depression of sense of thirst, skin losses, burns, sweating, hyperaldosteronism, CNS disorders, dilutional, depletional and delusional hyponatremia and syndrome of inappropriate ADH secretion.
| and delusional hyponatr | |
|---|---|
| ean Cooper | |
| (Division Sign-Off) | |
| Division of Clinical Laboratory | |
| vice: | |
| 510(k) Number | K993211 |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
ﺴﻠ Prescription Use (Per 21 CFR 801.109)
OR
Over- The Counter Use (Optional Format 1-2-96)
"