(86 days)
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No
The summary describes a standard in vitro diagnostic chemistry analyzer and reagent disc, with no mention of AI or ML in the device description, intended use, or performance studies.
No.
This device is for in vitro quantitative determination of HDL, used in diagnosis and treatment of lipid disorders, atherosclerosis, and various liver and renal diseases. It does not provide any therapeutic function.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is intended for the "in vitro quantitative determination of HDL" and that "Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders". This directly indicates its role in diagnosis.
No
The device description clearly outlines a physical reagent disc and a chemistry analyzer, indicating it is a hardware-based system for in vitro diagnostic testing, not a software-only device.
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 vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Sample Type: The device uses biological samples (heparinized whole blood, heparinized plasma, or serum) which are tested outside of the body.
- Purpose: The purpose is to provide quantitative measurements of HDL, which are used in the "diagnosis and treatment of lipid disorders". This aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description details how the device processes the sample and performs chemical reactions to obtain the results, which is typical of an IVD.
- Care Setting: The intended use in a "clinical laboratory setting or point-of-care location" further supports its use in a healthcare context for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Piccolo HDL Test System used with the Piccolo Point-of-Care Chemistry Analyzer is intended for the in vitro quantitative determination of HDL in heparinized whole blood, heparinized plasma, or serum 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)
LBS
Device Description
The Piccolo® Lipid Panel Reagent Disc (which contains the Piccolo® HDL 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
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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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Linearity:
Table 2: Summary of Linearity
Slope: 0.983
Intercept: 0.5
Correlation Coefficient (r): 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 (n =160)
HDL (mg/dL)
Serum 1: Mean 55.3, SD 1.4, %CV 2.6
Serum 2: Mean 38.0, SD 1.3, %CV 3.5
Total (n =160)
HDL (mg/dL)
Serum 1: Mean 55.3, SD 1.9, %CV 3.5
Serum 2: Mean 38.0, SD 1.6, %CV 4.3
Sample Type Comparison:
A study was conducted to examine and compare serum, heparinized plasma, and heparinized whole blood the Piccolo® Point-of-Care Chemistry Analyzer. The study included samples from 20 different patients. Each sample type was tested in quadruplicate. Serum, heparinized plasma and heparinized whole blood comparability was established for HDL.
Method Comparison:
Table 4: Method Comparison Data for HDL Assayed on the Using the Abaxis Piccolo® HDL Assay and the Roche HDL Assay
Piccolo CHOL Test System: n* 166, Mean 53.2, Std. Dev. 15.1, Range of Samples 25 - 90
Roche HDL Assay: n* 166, Mean 52.8, Std. Dev. 17.1, Range of Samples 23 - 97
Linear Regression: n* 166, Slope 0.851, Intercept 8.3, Correlation Coefficient (r) 0.965, Std. Error of the Estimate (SEE) 3.9
Deming Regression: n* 166, Slope 0.877, Intercept 6.9, Correlation Coefficient (r) 0.965, SEE N/A
- n = all data points (patient samples were run in duplicate and both values were plotted; number of patient samples = n/2)
The clinical and non-clinical tests performed using the Piccolo® HDL Test System. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 0.00799 A per mg/dL or 0.309 A per mmol/L; 15 mg/dL
Correlation Coefficient (r): 0.997 (Linearity), 0.965 (Method Comparison)
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.
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JAN 2 4 2003
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: K023640
1. Applicant Information:
| Date Prepared: | October 29, 2002 |
|---|---|
| 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) 441-6150 |
Device Information: 2.
| Classification | Class I |
|---|---|
| Trade Name: | Piccolo® HDL Test System |
Classification Name: HDL Test system 862.1475
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 | Manufacturer | 510(k) Number | Date of SE Determination |
|---|---|---|---|
| HDL-C plus | |||
| (HDL assay) Run | |||
| on a Hitachi 917 | |||
| Clinical Chemistry | |||
| Analyzer | Roche Diagnostics | K902935* | |
| (Roche Cobas | |||
| Ready HDL | |||
| Reagent) | 9/27/90 |
- Presumptive K number. NOTE: The predicate device is currently known as HDL-C plus, for use on Hitachi instrumentation. Since Roche and Hitachi have a co-marketing agreement, it is assumed that this submission (for the Cobas) is the predicate.
1
Description of the Device: 4.
The Piccolo® Lipid Panel Reagent Disc (which contains the Piccolo® HDL 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.
ട. Statement of Intended Use:
The Piccolo® Lipid Panel Reagent Disc (contains the Piccolo® HDL Test System) use with the Piccolo® Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of HDL 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® HDL Test System in comparison to the legally marketed predicate device.
2
Specification Comparison for Piccolo HDL (HDL) Test Table 1: System versus Roche HDL-RA Assay
| | Piccolo HDL Assay on Abaxis
Point-of-Care Chemistry
Analyzer | Roche Diagnostics HDL-C plus
Assay on Hitachi 917 Analyzer |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | 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 | Homogeneous enzymatic
colorimetric end-point test, making
use of dextran/sulfate suspension
and PEG-modified enzymes |
| Sample Type | Heparinized whole blood,
heparinized plasma, and
serum | Heparinized plasma and serum |
| Sensitivity | 0.00799 A per mg/dL or 0.309 A
per mmol/L; 15 mg/dL | 3 mg/dL |
| Reagents | Dry test-specific reagent beads
and liquid diluent; reconstitution
performed by analyzer | Liquid reagents |
| 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 | 15 - 100 mg/dL | 3 - 120 mg/dL |
| Testing Environment | Professional use | Professional use |
| Sample Size | Approx 100 µL | 3 µL |
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® HDL Test System.
3
Linearity:
Table 2: Summary of Linearity
| HDL | ||
|---|---|---|
| Slope | 0.983 | |
| Intercept | 0.5 | |
| Correlation Coefficient (r) | 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
(n =160) | Total
(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 |
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Sample Type Comparison:
A study was conducted to examine and compare serum, heparinized plasma, and heparinized whole blood the Piccolo® Point-of-Care Chemistry Analyzer. The study included samples from 20 different patients. Each sample type was tested in quadruplicate. Serum, heparinized plasma and heparinized whole blood comparability was established for HDL.
Method Comparison:
Table 4: Method Comparison Data for HDL Assayed on the Using the Abaxis Piccolo® HDL Assay and the Roche HDL Assay
| Parameters | Statistics | |
|---|---|---|
| Piccolo CHOL Test System | n* | 166 |
| Roche HDL Assay | n* | 166 |
| Piccolo HDL Test System | Mean | 53.2 |
| Roche HDL Assay | Mean | 52.8 |
| Piccolo HDL Test System | Std. Dev. | 15.1 |
| Roche HDL Assay | Std. Dev. | 17.1 |
| Piccolo HDL Test System | Range of Samples | 25 - 90 |
| Roche HDL Assay | Range of Samples | 23 - 97 |
| Linear Regression | Deming Regression | |
|---|---|---|
| n* | 166 | 166 |
| Slope | 0.851 | 0.877 |
| Intercept | 8.3 | 6.9 |
| Correlation Coefficient (r) | 0.965 | 0.965 |
| Std. Error of the Estimate (SEE) | 3.9 | N/A |
- n = all data points (patient samples were run in duplicate and both values were plotted; number of patient samples = n/2)
8. Conclusions
The clinical and non-clinical tests performed using the Piccolo® HDL Test System. 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.
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Image /page/5/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 symbol that resembles a caduceus, with three figures in profile facing right, representing health and human services.
Food and Druq Administration 2098 Gaither Road Rockville MD 20850
JAN 2 4 2003
Dennis M. Bleile, Ph.D. Director of Assay Development Abaxis, Inc. 3240 Whipple Road Union City, CA 94587
Re: K023640 Trade/Device Name: Piccolo HDL Test System Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I Product Code: LBS Dated: October 29, 2002 Received: October 30, 2002
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).
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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). 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 Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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12.0 INDICATIONS FOR USE STATEMENT
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Piccolo® HDL Test System Device Name:
Intended Use:
The Piccolo HDL Test System used with the Piccolo Point-of-Care Chemistry Analyzer is intended for the in vitro quantitative determination of HDL in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-ofcare location.
Indications for Use:
Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
(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) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | A023640 |