(50 days)
Not Found
No
The summary describes a standard in vitro diagnostic chemistry analyzer and reagent disc. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is an in vitro diagnostic (IVD) device used for the quantitative determination of phosphorus, which aids in the diagnosis and monitoring of various conditions, but it does not directly treat or prevent a disease.
Yes
The device determines phosphorus levels, which are explicitly stated to be used in the "diagnosis and treatment of renal insufficiency, hypoparathyroidism, vitamin D imbalance, a high calcium diet, hyperparathyroidism, and insulin treatment of diabetic ketacidosis." This direct link to diagnosis classifies it as a diagnostic device.
No
The device description clearly outlines a physical reagent disc and its interaction with a chemistry analyzer, indicating it is a hardware-based system, 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 phosphorus 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 results of the test are used for "diagnosis and treatment of renal insufficiency, hypoparathyroidism, vitamin D imbalance, a high calcium diet, hyperparathyroidism, and insulin treatment of diabetic ketacidosis." This indicates the test is used to provide information for medical diagnosis and treatment decisions.
- Device Description: The description details how the device processes the biological sample and performs chemical reactions to measure the analyte (phosphorus).
All these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Piccolo Phosphorus Test System (presently contained on the Renal Function Panel Reagent disc) used with the Piccolo Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of phosphorus in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.
Phosphorus The phosphorus assay is used for the quantitiation of phosphorus in human heparinized whole blood, heparinized plasma or serum. Phosphorus measurements are used in the diagnosis and treatment of renal insufficiency, hypoparathyroidism, vitamin D imbalance, a high calcium diet, hyperparathyroidism, and insulin treatment of diabetic ketacidosis.
Product codes (comma separated list FDA assigned to the subject device)
CEO
Device Description
The Piccolo Renal Function Panel Reagent Disc (which contains the Piccolo Phosphorus 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)
Linearity:
Slope: 1.00
Intercept: +0.2
Corr. Coefficient: 0.999
Sample Range: 2 - 17 mg/dL
Precision:
Within-Run (n = 80) and Total (n = 80) Precision for Phosphorus, Assayed on the Piccolo Point-of-Care Chemistry Analyzer:
Level 1 (Mean = 3.1): Within-Run SD = 0.12, Within-Run CV = 3.7; Total SD = 0.14, Total CV = 4.7
Level 2 (Mean = 7.3): Within-Run SD = 0.09, Within-Run CV = 1.3; Total SD = 0.15, Total CV = 2.0
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 phosphorus. Phosphorous concentrations in serum are 0.3 mg/dL higher than in heparinized plasma and heparinized whole blood.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 0.2 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
§ 862.1580 Phosphorus (inorganic) test system.
(a)
Identification. A phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
5 2002 SEP
3240 Whipple Road, Union City, CA 94587 Phone 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: K022312
1. Applicant Information:
| Date Prepared: | July 15, 2002 |
|---|---|
| Name: | Abaxis, Inc. |
| Address: | 3240 Whipple Road |
| Union City, CA 94587 | |
| Contact Person: | Robert Milder |
| Contact Person: | Robert Milder |
|---|---|
| Phone Number: | (510) 675-6524 |
| Fax Number: | (510) 441-6150 |
2. Device Information:
Classification Class I Piccolo® Phosphorus Test System Trade Name:
Classification Name:
Phosphorus (Inorganic) Test system 862.1580
3. ldentification of legally marketed device to which the submitter claims 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 | |||
| Phosphorus Slides on | |||
| the Vitros 950 | |||
| Chemistry System | Johnson and | ||
| Johnson Clinical | |||
| Diagnostics | K932729 | 8/3/93 |
1
Summary of Safety and Effectiveness,
4. Description of the Device:
The Piccolo Renal Function Panel Reagent Disc (which contains the Piccolo Phosphorus 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.
5. Statement of Intended Use:
The Piccolo Renal Function Panel Reagent Disc (contains the Piccolo Phosphorus Test System) use with the Piccolo Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of phosphorus 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 Phosphorus 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 phosphorus | Quantitative analysis of phosphorus |
| Methodology | Enzymatic endpoint reaction | Colorimetric |
| Sample Type | Heparinized whole blood,
heparinized plasma and serum | Heparinized plasma, serum and urine |
| Sensitivity | 0.2 mg/dL | 0.5 mg/dL |
| Reagents | Dry test-specific reagent beads | p-Methylaminophenol sulfate and
ammonium molybdate |
| Temperature | 37°C | 37°C |
| Calibration | Bar code with factory
calibrated lot specific data | Calibrated periodically using
calibrators supplied by vendor |
| Assay Range | 0.2 - 20 mg/dL | 0.5 - 13.0 mg/dL |
| Testing Environment | Professional use | Professional use |
| Sample Size | 100 µL | 10 µL |
Table 1: Specification Comparison: Piccolo Phosphorus Test System
2
Summary of Safety and Effectiveness,
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® Phosphorus Test System.
Linearity:
| Phosphorus | |
|---|---|
| Slope | 1.00 |
| Intercept | +0.2 |
| Corr. Coefficient | 0.999 |
| Sample Range | 2 - 17 mg/dL |
Table 2: Summary of Linearity
Precision:
Precision studies were designed to evaluate within-run and total precision of phosphorus included on the Piccolo Renal Function Panel Reagent Disc when run on the Piccolo Point-of-Care Chemistry Analyzer.
Table 3: Within-Run and Total Precision for Phosphorus, Assayed on the Piccolo Point-of-Care Chemistry Analyzer
| Analyte | Within-Run
(n = 80) | Total
(n = 80) |
|-------------------------------|------------------------|-------------------|
| Phosphorus (mg/dL)
Level 1 | | |
| Mean | 3.1 | 3.1 |
| SD | 0.12 | 0.14 |
| CV | 3.7 | 4.7 |
| Level 2 | | |
| Mean | 7.3 | 7.3 |
| SD | 0.09 | 0.15 |
| CV | 1.3 | 2.0 |
3
Summary of Safety and Effectiveness,
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 phosphorus. Phosphorous concentrations in serum are 0.3 mg/dL higher than in heparinized plasma and heparinized whole blood.
8. Conclusions
The clinical and non-clinical tests performed for phosphorus, 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
Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The seal is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
5 2002 SEP
Mr. Robert Milder Chief of Operations Officer Abaxis Inc. 3240 Whipple Road Union City, CA 94587
Re: K022312
Trade/Device Name: Piccolo® Phosphorus Test System Regulation Number: 21 CFR 862.1580 Regulation Name: Phosphorus (inorganic) Test System Regulatory Class: Class I Product Code: CEO Dated: July 15, 2002 Received: July 17, 2002
Dear Mr. Milder:
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 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
5
Page 2 -
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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Steven Butman
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 STATEMENT 12.0
Indications for Use
510(k) Number (if known): K022312
Piccolo® Phosphorus Test System Device Name:
Intended Use:
The Piccolo Phosphorus Test System (presently contained on the Renal Function Panel Reagent disc) used with the Piccolo Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of phosphorus in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.
Indications for Use:
Phosphorus The phosphorus assay is used for the quantitiation of phosphorus in human heparinized whole blood, heparinized plasma or serum. Phosphorus measurements are used in the diagnosis and treatment of renal insufficiency, hypoparathyroidism, vitamin D imbalance, a high calcium diet, hyperparathyroidism, and insulin treatment of diabetic ketacidosis.
Jtan Coog
(Division Sign-Off)
Division of Clinical Labora!
510(k) Number K022312
(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)