(50 days)
Not Found
No
The summary describes a chemical analysis system based on reagent reactions and optical monitoring, with no mention of AI/ML terms or concepts.
No
The device is used for in vitro quantitative determination of HDL in capillary whole blood, which is a diagnostic function, not a therapeutic one. It provides information for diagnosis and treatment of conditions, but does not directly treat them.
Yes
The device is described as being used for the "diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases," which is a diagnostic purpose.
No
The device description clearly states it is a "Reagent Disc" which is a physical component used with a chemistry analyzer, indicating it is 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 intended for the "in vitro quantitative determination of HDL in capillary (fingerstick) heparinized whole blood". "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Device Description: The description details how the device processes a blood sample (separating plasma, mixing with diluent and reagents) to perform chemical reactions that are then monitored. This process is typical of an IVD that analyzes biological samples.
- Clinical Laboratory Setting or Point-of-Care Location: The intended use specifies that the device is used in a clinical laboratory setting or point-of-care location, which are common environments for IVD testing.
- Diagnosis and Treatment: The intended use also mentions that the measurements are used in the "diagnosis and treatment of lipid disorders," which is a direct application of IVD results.
All of these points align with the definition and purpose of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Piccolo HDL - Capillary Test System used with the Piccolo xpress Chemistry Analyzer is intended for the in vitro quantitative determination of HDL in capillary (fingerstick) heparinized whole blood in a clinical laboratory setting or point-of-care location.
Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
Product codes (comma separated list FDA assigned to the subject device)
JHM
Device Description
The Piccolo® Lipid Panel – Capillary Reagent Disc (which contains the Piccolo® HDL - 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
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: 0.983
Intercept: 0.5
Correlation Coefficient (r): 0.997
Precision:
Study Type: Within-run and total precision studies
Sample Size: n = 160 for both within-run and total precision.
Key Results:
HDL (mg/dL) Serum 1:
Mean: 55.3
Within-Run SD: 1.4, %CV: 2.6
Total SD: 1.9, %CV: 3.5
HDL (mg/dL) Serum 2:
Mean: 38.0
Within-Run SD: 1.3, %CV: 3.5
Total SD: 1.6, %CV: 4.3
Method Comparison:
Study Type: Method Comparison (Abaxis Piccolo HDL -Capillary Test System vs. Roche HDL Test)
Sample Size: N = 559
Key Results:
Piccolo HDL - Capillary:
Mean: 47.2
Std. Dev.: 13.9
Range of Samples: 21 - 93
Roche HDL Test:
Mean: 49.3
Std. Dev: 13.8
Range of Samples: 23 - 92.5
Linear Regression (Roche on X Axis):
N: 559
Slope (95% CI): 0.99 (0.97 to 1.01)
Intercept: -1.6 (-2.4 to -0.8)
Correlation Coefficient (R2): 0.962
Std. Error of the Estimate (SEE): 2.7
Deming Regression (Roche on X Axis):
N: 559
Slope (95% CI): 1.01 (0.99 to 1.03)
Intercept: -2.6 (-3.4 to -1.7)
Correlation Coefficient (R2): 0.962
Std. Error of the Estimate (SEE): 2.7
Conclusions: The clinical and non-clinical tests demonstrate that the test system is as safe, effective and performs as well as the legally marketed devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found. Key metrics are Slope, Intercept, Correlation Coeff. (r), Standard Deviation, %CV, Correlation Coefficient (R2), Std. Error of the Estimate (SEE).
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
§ 862.1475 Lipoprotein test system.
(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(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
APR 2 4 2012
3240 Whipple 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:
1. Applicant Information:
| Date Prepared: | March 2, 2012 |
|---|---|
| Name: | Abaxis, Inc. |
| Address: | 3240 Whipple Road Union City, CA 94587 |
Contact Person: Dennis M. Bleile, PhD Phone Number: (510) 675-6515 Fax Number: (510) 405-8871
Device Information: 2.
Classification Class I Piccolo® HDL - Capillary Test System Trade Name:
Classification Name: HDL Test system 862.1475
3. Identification of Legally Marketed Device to which the Submitter Claims Equivalence:
The following table identifies the legally marketed devices to which Abaxis claims equivalence:
| Predicate Device | |||
|---|---|---|---|
| Predicate Device | Manufacturer | 510(k) Number | Date of SE Determination |
| Piccolo® HDL Test | |||
| System | Abaxis | K023640 | 1/24/2003 |
| Cobas® HDL- | |||
| Cholesterol Plus 3rd | |||
| Generation | Roche Diagnostics | ||
| Indianapolis, IN | K033610 | 12/05/2003 |
1
Summary of Safety and Effectiveness (continued)
4. Description of the Device:
The Piccolo® Lipid Panel – Capillary Reagent Disc (which contains the Piccolo® HDL - 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.
5. Statement of Intended Use:
The Piccolo HDL - Capillary Test System used with the Piccolo xpress Chemistry Analyzer is intended for the in vitro quantitative determination of HDL in capillary (fingerstick) heparinized whole blood 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® HDL - Capillary Test System in comparison to the legally marketed predicate device.
2
Piccolo® HDL (High Density Lipoprotein Cholestero
- Capillary Test System
Summary of Safety and Effectiveness (continued
able 1: Specification Comparison for Piccolo HDL – Capillary Test System, Piccolo HDL Test System, and the Roche HD
est on the Cobas 6000 Analyzer
| Piccolo HDL - Capillary Test System on Abaxis Chemistry Analyzer | Piccolo HDL Test System on Abaxis Chemistry Analyzer | Roche Diagnostics Cobas® HDL-Cholesterol Plus 3rd Generation Test | |
|---|---|---|---|
| Intended Use | Quantitative analysis of HDL | Quantitative analysis of HDL | Quantitative analysis of HDL |
| Methodology | Hybrid enzymatic colorimetric end-point test, making use of dextran/sulfate precipitation, centrifugation, and PEG-modified enzymes | Hybrid enzymatic colorimetric end-point test, making use of dextran/sulfate precipitation, centrifugation, and PEG-modified enzymes | Homogeneous enzymatic colorimetric end-point test, making use of dextran/sulfate suspension and PEG-modified enzymes |
| 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 | 15 mg/dL | 15 mg/dL | 3 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 reagents |
| 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 | 15 - 100 mg/dL | 15 - 100 mg/dL | 3 - 120 mg/dL |
| Testing Environment | Professional use | Professional use | Professional use |
3
Summary of Safety and Effectiveness (continued)
Brief Discussion of the Clinical and Nonclinical Tests Relied on for a 7. Determination of Substantial Equivalence.
The following information summarizes the results of clinical and non-clinical tests performed using the Piccolo® HDL Test System.
Linearity:
| Table 2: Summary of Linearity | ||
|---|---|---|
| HDL | ||
| Slope | 0.983 | |
| Intercept | ||
| Correlation Coefficient (r) | 0.5 | |
| 0.997 | ||
Precision:
Precision studies were designed to evaluate within-run and total precision of HDL included on the Piccolo® Lipid Panel Reagent Disc when run on the Piccolo® Pointof-Care Chemistry Analyzer.
Table 3: Within-Run and Total Precision of HDL Assayed on the Piccolo Point-of-Care Chemistry Analyzer
| Within-Run | Total | |
|---|---|---|
| (n =160) | (n =160) | |
| HDL (mg/dL) | ||
| Serum 1 | ||
| Mean | 55.3 | 55.3 |
| SD | 1.4 | 1.9 |
| %CV | 2.6 | 3.5 |
| Serum 2 | ||
| Mean | 38.0 | 38.0 |
| SD | 1.3 | 1.6 |
| %CV | 3.5 | 4.3 |
4
Summary of Safety and Effectiveness (continued)
Method Comparison:
Table 4: Method Comparison Data for HDL Assayed by the Abaxis Piccolo HDL -Capillary Test System and the Roche HDL. Test
| Parameters | Statistics |
|---|---|
| Piccolo HDL - Capillary: Singlicate Values, N | 559 |
| Roche HDL Test: Average of Duplicates, N | 559 |
| Piccolo HDL - Capillary: Mean | 47.2 |
| Roche HDL Test: Mean | 49.3 |
| Piccolo HDL - Capillary: Std. Dev. | 13.9 |
| Roche HDL Test: Std. Dev | 13.8 |
| Piccolo HDL - Capillary: Range of Samples | 21 - 93 |
| Roche HDL Test: Range of Samples | 23 - 92.5 |
| Parameters (Roche on X Axis) | Linear Regression | Deming Regression |
|---|---|---|
| N | 559 | 559 |
| Slope (95% CI) | 0.99 (0.97 to 1.01) | 1.01 (0.99 to 1.03) |
| Intercept | -1.6 (-2.4 to -0.8) | -2.6 (-3.4 to -1.7) |
| Correlation Coefficient (R2) | 0.962 | 0.962 |
| Std. Error of the Estimate (SEE) | 2.7 | 2.7 |
Conclusions 8.
The clinical and non-clinical tests performed using the Piccolo® HDL – Capillary Test System, when run on the Piccolo xpress Chemistry Analyzer, demonstrate that the test system is as safe, effective and performs as well as the legally marketed devices identified above.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
Abaxis Inc. c/o Dennis Bleile, Ph.D. 3240 Whipple Road Union City, CA 94587
Re: K120662
Trade/Device Name: Piccolo® HDL Capillary Test System Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: . Class I, meets limitations of exemptions per 21 CFR 862.9 (c)(9) Product Code: JHM 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 class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
APR 2 4 2012
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,
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
INDICATIONS FOR USE STATEMENT 12.0
Indications for Use
K120662 510(k) Number (if known):
Piccolo® HDL - Capillary Test System Device Name:
Indications for Use:
The Piccolo HDL - Capillary Test System used with the Piccolo xpress Chemistry Analyzer is intended for the in vitro quantitative determination of HDL in capillary (fingerstick) heparinized whole blood in a clinical laboratory setting or point-of-care location.
Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
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) K120662
Page 1 of 1
(Optional Format 1-2-96)