(50 days)
Not Found
No
The summary describes a chemical analysis system for measuring triglycerides, with no mention of AI or ML in the device description, performance studies, or key metrics.
No
The device is used for the quantitative determination of triglycerides to aid in diagnosis and treatment, but it does not directly treat or restore bodily functions. It's an in vitro diagnostic device.
Yes
The "Intended Use / Indications for Use" section states that "Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism, or various endocrine disorders," indicating its use in diagnosing conditions.
No
The device description clearly outlines a physical reagent disc and its interaction with an 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 / Indications for Use" section explicitly states that the system is for the "in vitro quantitative determination of triglycerides in capillary (fingerstick) heparinized whole blood". "In vitro" means "in glass" or "outside of the body," which is a key characteristic of IVDs.
- Measurement: The device measures a substance (triglycerides) in a biological sample (whole blood) to provide information for diagnosis and treatment. This is the core function of an IVD.
- Clinical Context: The intended use also mentions that the measurements are used in the "diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism, or various endocrine disorders." This clearly indicates a clinical purpose for the test results.
- Device Description: The description details how the device processes the blood sample and performs chemical reactions to obtain the measurement, which is consistent with how IVDs function.
Therefore, based on the provided information, the Piccolo Triglycerides - Capillary Test System is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Piccolo Triglycerides - Capillary Test System used with the Piccolo xpress Chemistry Analyzer is intended for the in vitro quantitative determination of triglycerides in capillary (fingerstick) heparinized whole blood in a clinical laboratory setting or point-of-care location.
Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism, or various endocrine disorders.
Product codes (comma separated list FDA assigned to the subject device)
JGY
Device Description
The Piccolo® Lipid Panel - Capillary Reagent Disc (which contains the Piccolo® Triglycerides - Capillary 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.
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
in a clinical laboratory setting or point-of-care location.
Professional use
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:
Table 2: Summary of Linearity
Triglycerides
Slope: 1.000
Intercept: 3.0
Correlation Coefficient (r): 1.000
Precision:
Precision studies were designed to evaluate within-run and total precision of
triglycerides included on the Piccolo® Lipid Panel Reagent Disc when run on the Abaxis analyzer.
Table 3: Within-Run and Total Precision of Triglycerides Assayed on the Abaxis Analyzer
Within-Run (n =160)
Triglycerides (mg/dL)
Serum 1
Mean: 206.8
SD: 4.7
%CV: 2.3
Serum 2
Mean: 163.7
SD: 1.8
%CV: 1.1
Total (n =160)
Triglycerides (mg/dL)
Serum 1
Mean: 206.8
SD: 5.5
%CV: 2.6
Serum 2
Mean: 163.7
SD: 2.4
%CV: 1.5
Method Comparison:
Table 4: Method Comparison Data for Triglycerides Assayed by the Abaxis Piccolo Triglycerides - Capillary Test System and the Roche Triglycerides Test
Parameters
Piccolo Triglycerides - Capillary: Singlicate Values, N: 588
Roche Triglycerides Assay: Average of Duplicates, N: 588
Piccolo Triglycerides - Capillary: Mean: 155.4
Roche Triglycerides Assay: Mean: 157.5
Piccolo Triglycerides - Capillary: Std. Dev.: 88.3
Roche Triglycerides Assay: Std. Dev: 91.6
Piccolo Triglycerides - Capillary: Range of Samples: 36 - 496
Roche Triglycerides Assay: Range of Samples: 33.5 - 528
Parameters (Roche on X Axis)
Linear Regression
N: 588
Slope (95% CI): 0.96 (0.95 to 0.97)
Intercept (95% CI): 4.1 (2.8 - 5.4)
Correlation Coefficient (R²): 0.992
Std. Error of the Estimate (SEE): 7.9
Deming Regression
N: 588
Slope (95% CI): 0.96 (0.95 to 0.97)
Intercept (95% CI): 3.5 (2.1 to 4.9)
Correlation Coefficient (R²): 0.992
Std. Error of the Estimate (SEE): 7.9
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 862.1705 Triglyceride test system.
(a)
Identification. A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.(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 § 862.9.
0
Piccolo® Triglycerides - Capillary Test System
510(k) Premarket Notification
K120664
APR 24 2012
APPENDIX D
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
3240 Whipple Road, Union City, CA 94587 Phone 510 . 675-6500 Fax 510 . 441-6150
Image /page/0/Picture/20 description: The image shows the word "ABAXIS" in a bold, sans-serif font. A stylized oval shape encircles the "X" in the word, adding a dynamic element to the design. The overall impression is clean and modern, suggesting a professional and innovative company.
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:
1. Applicant Information:
| Date Prepared:
Name:
Address: | March 2, 2012
Abaxis, Inc.
3240 Whipple Road
Union City, CA 94587 | |
|-------------------------------------|----------------------------------------------------------------------------|--|
| Contact Person:
Dhana Mundau | Dennis M. Bleile, PhD
ICHOS COLE | |
| Contact Person: | Dennis M. Bielle, PhD |
|---|---|
| Phone Number: | (510) 675-6515 |
| Fax Number: | (510) 441-6150 |
2. Device Information:
| Classification | Class I |
|---|---|
| Trade Name: | Piccolo® Triglycerides - Capillary Test System |
Classification Name: Triglycerides Test system 862.1705
3. Identification of Legally Marketed Devices to which the Submitter Claims Equivalence:
The following table identifies the legally marketed device to which Abaxis claims equivalence:
| Predicate Devices | |||
|---|---|---|---|
| Predicate Device | Manufacturer | 510(k) | |
| Number | Date of SE | ||
| Determination | |||
| Piccolo® Triglycerides | |||
| Test System | Abaxis | ||
| Union City, CA | K023639 | 1/24/2003 | |
| Cobas® Triglycerides | |||
| Test | Roche Diagnostics | ||
| Indianapolis, IN | K893973 | 08/11/1989 |
1
Summary of Safety and Effectiveness (continued)
4. Description of the Device:
The Piccolo® Lipid Panel - Capillary Reagent Disc (which contains the Piccolo® Triglycerides - Capillary 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.
Statement of Intended Use: 5.
The Piccolo Triglycerides - Capillary Test System used with the Piccolo xpress Chemistry Analyzer is intended for the in vitro quantitative determination of triglycerides in capillary (fingerstick) heparinized whole blood in a clinical laboratory setting or point-of-care location.
Summary of the Technological Characteristics of the New Device in 6. Comparison to those of the Predicate Device:
Table 1 outlines the technological characteristics of the Piccolo® Triglycerides -Capillary Test System in comparison to the legally marketed predicate device.
2
ಿ Triglycerides - Capillary Test System Picc
Summary of Safety and Effectiveness (continued)
.
Table 1: Specification Comparison for Piccolo Triglycerides – Capillary Test System, Piccolo Triglycerides Test System
and the Roche Triglycerides Test on the Cobas 6000 Ana
| | Piccolo Triglycerides –
Capillary Test on Abaxis
Chemistry Analyzer | Piccolo Triglycerides Test on
Abaxis Chemistry Analyzer | Roche Triglycerides Test on
the Cobas 6000 Analyzer |
|------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Intended Use | Quantitative analysis of
Triglycerides | Quantitative analysis of
Triglycerides | Quantitative analysis of
Triglycerides |
| Methodology | Enzymatic endpoint reaction | Enzymatic endpoint reaction | Enzymatic endpoint reaction |
| Sample Type | Lithium heparinized capillary whole
blood | Lithium heparinized whole blood,
heparinized plasma, and
serum | Lithium heparin and potassium
EDTA plasma and serum |
| Dynamic Range
Lower Limit | 20 mg/dL | 20 mg/dL | 3.86 mg/dL |
| Reagents | Dry test-specific reagent beads
and liquid diluent; reconstitution
performed by analyzer | Dry test-specific reagent beads
and liquid diluent; reconstitution
performed by analyzer | Liquid reagent |
| Temperature of
Reaction | 37°C | 37°C | 37°C |
| Calibration | Bar code with factory
calibrated lot specific data | Bar code with factory
calibrated lot specific data | Calibrated periodically using
calibrators supplied by vendor |
| Assay Range | 20-500 mg/dL | 20-500 mg/dL | 8.85-885 mg/dL |
| Testing Environment | Professional use | Professional use | Professional use |
| Sample Size | Approx 100 µL | Approx 100 μL | 2 µL |
baxis Confidentia
・ . .
3
Summary of Safety and Effectiveness (continued)
7. Brief Discussion of the Clinical and Nonclinical Tests Relied on for a Determination of Substantial Equivalence.
The following information summarizes the results of clinical and non-clinical tests performed using the Piccolo® Triglycerides Test System.
Linearity:
Table 2: Summary of Linearity
| Triglycerides | |
|---|---|
| Slope | 1.000 |
| Intercept | 3.0 |
| Correlation Coefficient (r) | 1.000 |
Precision:
Precision studies were designed to evaluate within-run and total precision of
triglycerides included on the Piccolo® Lipid Panel Reagent Disc when run on the Abaxis analyzer.
Table 3: Within-Run and Total Precision of Triglycerides Assayed on the Abaxis Analyzer
| | Within-Run
(n =160) | Total
(n =160) |
|-----------------------|------------------------|-------------------|
| Triglycerides (mg/dL) | | |
| Serum 1 | | |
| Mean | 206.8 | 206.8 |
| SD | 4.7 | 5.5 |
| %CV | 2.3 | 2.6 |
| Serum 2 | | |
| Mean | 163.7 | 163.7 |
| SD | 1.8 | 2.4 |
| %CV | 1.1 | 1.5 |
4
Summary of Safety and Effectiveness (continued)
Method Comparison:
Table 4: Method Comparison Data for Triglycerides Assayed by the Abaxis Piccolo Triglycerides - Capillary Test System and the Roche Triglycerides Test
| Parameters | Statistics |
|---|---|
| Piccolo Triglycerides - Capillary: Singlicate Values, N | 588 |
| Roche Triglycerides Assay: Average of Duplicates, N | 588 |
| Piccolo Triglycerides - Capillary: Mean | 155.4 |
| Roche Triglycerides Assay: Mean | 157.5 |
| Piccolo Triglycerides - Capillary: Std. Dev. | 88.3 |
| Roche Triglycerides Assay: Std. Dev | 91.6 |
| Piccolo Triglycerides - Capillary: Range of Samples | 36 - 496 |
| Roche Triglycerides Assay: Range of Samples | 33.5 - 528 |
| Parameters (Roche on X Axis) | Linear Regression | Deming Regression |
|---|---|---|
| N | 588 | 588 |
| Slope (95% CI) | 0.96 (0.95 to 0.97) | 0.96 (0.95 to 0.97) |
| Intercept (95% CI) | 4.1 (2.8 - 5.4) | 3.5 (2.1 to 4.9) |
| Correlation Coefficient (R²) | 0.992 | 0.992 |
| Std. Error of the Estimate (SEE) | 7.9 | 7.9 |
8. Conclusions
The clinical and non-clinical tests performed using the Piccolo® Triglycerides =
Capillary Test System, when run on the Piccolo xpress Chemistry Analyzer, Supillary - Foot - System is as safe, effective and performs as well as the legally marketed devices identified above.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 a human figure, represented by flowing lines, suggesting a sense of movement and connection.
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
Abaxis, Inc. c/o Dennis M. Bleile, Ph.D., RAC Director of Assay Performance and Compliance 3240 Whipple Road Union City, CA 94587
APR 2 4 2012
Re: K120664
Trade/Device Name: Piccolo Triglycerides - Capillary Test System Regulation Number: 21 CFR 862.1705 Regulation Name: Triglyceride Test System Regulatory Class: Class I, meets limitations of exemptions per 21 CFR 862.9 (c)(4) Product Code: JGY Dated: March 2, 2012 Received: March 5, 2012
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 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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.
6
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ...
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) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm
Sincerely yours,
$\mathcal{N}$
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
Piccolo® Triglycerides - Capillary Test System
INDICATIONS FOR USE STATEMENT 12.0
Indications for Use
510(k) Number (if known):
Piccolo® Triglycerides Test System Device Name:
Intended Use:
The Piccolo Triglycerides - Capillary Test System used with the Piccolo xpress Chemistry Analyzer is intended for the in vitro quantitative determination of triglycerides in capillary (fingerstick) heparinized whole blood in a clinical laboratory setting or point-of-care location.
Indications for Use:
Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism, or various endocrine disorders.
Prescription Use × (Part 21 CFR 801.109 Subpart D) AND/OR
Over- The Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K12066
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