(67 days)
Not Found
No
The summary describes a standard in vitro diagnostic test system for measuring lactate dehydrogenase activity using chemical reactions and photometric analysis. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is an in vitro diagnostic (IVD) system used to measure lactate dehydrogenase activity, which aids in the diagnosis and treatment of certain conditions, but it does not directly treat or prevent a disease.
Yes
The device is described as being used for the "quantitative determination of lactate dehydrogenase activity" and that these "measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis and cirrhosis; cardiac diseases such as myocardial infarction; malignant diseases; and tissue alterations of the heart, kidney, liver, and muscle." This explicitly states its role in diagnosis.
No
The device description clearly describes a physical reagent disc and an analyzer, indicating it is a hardware-based system for in vitro diagnostic testing, 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 lactate dehydrogenase activity in heparinized plasma or serum". "In vitro" means outside of the living body, and the analysis is performed on biological samples (plasma or serum).
- Sample Type: The device is designed to analyze biological samples (heparinized plasma or serum).
- Purpose: The measurements are used for "diagnosis and treatment of liver diseases... cardiac diseases... malignant diseases; and tissue alterations". This aligns with the purpose of IVD devices, which are used to provide information for diagnosis, monitoring, or treatment decisions.
- Device Description: The description details how the device processes the biological sample and performs chemical reactions to obtain a result.
The definition of an IVD device generally includes products used to examine specimens derived from the human body to provide information for diagnostic purposes. This device clearly fits that description.
N/A
Intended Use / Indications for Use
The Piccolo Lactate Dehydrogenase Test System (presently contained on the Piccolo Basic Metabolic Panel Plus Reagent Disc) used with the Piccolo Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of lactate dehydrogenase activity in heparinized plasma or serum in a clinical laboratory setting or point-of-care location.
Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis and cirrhosis; cardiac diseases and tissue alterations of the heart, kidney, liver, and muscle.
Product codes (comma separated list FDA assigned to the subject device)
CFJ
Device Description
The Piccolo Basic Metabolic Panel Plus Reagent Disc (which contains the Piccolo The Thoolo Dacto MetaTest System) is designed for heparinized plasma and serum, only. The disc meters the required quantity of sample and diluent, mixes the sample with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted samples 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: 1.012
Intercept: +0.253
Corr. Coefficient: 0.998
Precision:
Precision studies were designed to evaluate within-run and total precision of the Lactate Dehydrogenase Test System when run on the Piccolo Point-of-Care Chemistry Analyzer.
Within-Run (n = 80):
Control Level 1: Mean = 87, SD = 3.0, %CV = 3.4
Control Level 2: Mean = 350, SD = 3.8, %CV = 1.1
Total (n = 80):
Control Level 1: Mean = 87, SD = 4.4, %CV = 5.0
Control Level 2: Mean = 350, SD = 7.0, %CV = 2.0
Sample Type Comparison:
A study was conducted to examine and compare results for heparinized plasma and serum on the Piccolo® Point-of-Care Chemistry Analyzer.
Heparinized plasma and serum comparability were established for Lactate Dehydrogenase.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 50 U/L
Assay Range: 50 - 1,000 U/L
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
§ 862.1440 Lactate dehydrogenase test system.
(a)
Identification. A lactate dehydrogenase test system is a device intended to measure the activity of the enzyme lactate dehydrogenase in serum. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
0
JUL - 8 2005
3240 Whipple Road, Union City, CA 94587 510 · 675-6500 Fax 510 · 441-6150 Phone
Image /page/0/Picture/4 description: The image shows the logo for ABAXIS. The logo is in black and white and features the company name in bold, sans-serif font. A stylized oval shape encircles the letters 'XIS' of the company name, adding a visual element to the logo.
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: | April 29, 2005 |
|---|---|
| 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 II |
|---|---|
| Trade Name: | Piccolo® Lactate Dehydrogenase Test System |
Classification Name: Lactate Dehydrogenase Test system 862.1440
Identification of legally marketed device to which the submitter claims 3. 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 | |||
| Lactate Dehydrogenase | |||
| Reagents on the | |||
| Synchron LX20 | |||
| Chemistry System | Beckman Coulter, | ||
| Inc. (Brea, CA) | K011213 | 5/16/01 |
Description of the Device: 4.
The Piccolo Basic Metabolic Panel Plus Reagent Disc (which contains the Piccolo The Thoolo Dacto MetaTest System) is designed for heparinized plasma and serum, only. The disc meters the required quantity of sample and diluent, mixes
1
Summary of Safety and Effectiveness (continued)
the sample with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted samples 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 Lactate Dehydrogenase Test System (presently contained on the Basic Metabolic Panel Plus Reagent Disc) used with the Piccolo Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of lactate dehydrogenase activity in heparinized plasma or serum in a clinical laboratory setting or point-of-care location.
Summary of the technological characteristics of the new device in comparison 6. to those of the predicate device:
outlines the technological characteristics of the Piccolo Lactate ← Table Dehydrogenase Test System in comparison to the legally marketed predicate device.
| | Piccolo Point-of-Care
Chemistry Analyzer | Synchron LX20 Chemistry
System |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Intended Use | Quantitative analysis of
Lactate Dehydrogenase | Quantitative analysis of
Lactate Dehydrogenase |
| Methodology | Enzymatic rate reaction | Enzymatic rate reaction |
| Sample Type | Heparinized plasma and serum | Heparinized plasma and serum |
| Sensitivity | 50 U/L | 5 U/L |
| Reagents | Dry test-specific reagent beads
and liquid diluent; reconstitution
performed by analyzer
Active ingredients:
Lactate
Nicotinamide adenine
dicucleotide (NAD+)
Diaphorase
p-Iodonitrotetrazolium Violet
(INT) | Liquid reagents
Active ingredients:
Lactate
Nicotinamide adenine
dicucleotide (NAD+) |
| Temperature of
Reaction | 37°C | 37°C |
| Calibration | Bar code with factory
calibrated lot specific data | Calibration not required. |
| Assay Range | 50 - 1,000 U/L | 5 - 750 U/L
(600 - 2,700 U/L ORDAC*) |
| Testing Environment | Professional use | Professional use |
Table 1: Specification Comparison: Piccolo Lactate Dehydrogenase Test System
2
Summary of Safety and Effectiveness (continued)
Table 1: Specification Comparison: Piccolo Lactate Dehydrogenase Test System (continued)
| | Piccolo Point-of-Care
Chemistry Analyzer | Synchron LX20 Chemistry
System |
|-------------|---------------------------------------------|-----------------------------------|
| Sample Size | Approximately 100 µL | 13 µL
(3 µL ORDAC*) |
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 Lactate Dehydrogenase Test System.
Linearity:
Table 2: Summary of Linearity
| | Lactate
Dehydrogenase | |
|-------------------|--------------------------|--|
| Slope | 1.012 | |
| Intercept | +0.253 | |
| Corr. Coefficient | 0.998 | |
3
Summary of Safety and Effectiveness (continued)
Precision:
Precision studies were designed to evaluate within-run and total precision of the Lactate Dehydrogenase Test System when run on the Piccolo Point-of-Care Chemistry Analyzer.
Table 3: Within-Run and Total Precision for Lactate Dehydrogenase, Assayed on the Piccolo Point-of-Care Chemistry Analyzer
| Analyte | Within-Run
(n = 80) | Total
(n = 80) |
|-----------------------------|------------------------|-------------------|
| Lactate Dehydrogenase (U/L) | | |
| Control Level 1 | | |
| Mean | 87 | 87 |
| SD | 3.0 | 4.4 |
| %CV | 3.4 | 5.0 |
| Control Level 2 | | |
| Mean | 350 | 350 |
| SD | 3.8 | 7.0 |
| %CV | 1.1 | 2.0 |
Sample Type Comparison:
A study was conducted to examine and compare results for heparinized plasma and serum on the Piccolo® Point-of-Care Chemistry Analyzer.
Heparinized plasma and serum comparability were established for Lactate Dehydrogenase.
Conclusions 8.
The clinical and non-clinical tests performed for Lactate Dehydrogenase, 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
.
:
Abaxis Confidential
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized eagle with three stripes forming its wing and body. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the top half of the circle.
Public Health Service
JUL - 8 2005
Food and Drug Administrat 2098 Gaither Road Rockville MD 20850
Dennis M. Bleile Ph.D. Director of Assay Performance &Compliance Abaxis, Inc 3240 Whipple Road Union City, CA 94587
Re: K051108
K031100
Trade/Device Name: Piccolo® Lactate Dehydrogenase Test Regulation Number: 21 CFR 862.1440 Regulation Name: Lactate dehydrogenase test system Regulatory Class: Class II Product Code: CFJ Dated: April 29, 2005 Received: May 2, 2005
Dear Dr. Bleile:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for the stated in the encrosure) to regard nent date of the Medical Device Amendments, or to commerce prof to May 20, 1977, the enacements with the provisions of the Federal Food, Drug, devices mail have been recuire approval of a premarket approval application (PMA). alle Cosmetic Act (71cc) market the device, subject to the general controls provisions of the Act. The 1 ou may, mercrore, market the act include requirements for annual registration, listing of general controls provisions of aactice, 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 it may be subject to Sach additions (CFR), Parts 800 to 895. In addition, FDA can oc nound in This 21, Courtents concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that i Dr i loseants of the complies with other requirements of the Act that IDA has made a determinations administered by other Federal agencies. You must of any reactal statutes and regaranents ancluding, but not limited to: registration and listing (21 Comply with an the Free Stocker Parts 801 and 809); and good manufacturing practice CI K Part 807), tabeling systems (QS) regulation (21 CFR Part 820).
6
Page 2 -
This letter will allow you to begin marketing your device as described in your section 5 10(k) I his letter will anow you to begin manketing your antial equivalence of your device to a legally premarked notification. The PDT Intuing of basicance of the super and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, If you desire specific intornation advartising of your device, please contact the Office of In
or questions on the promotion and advertising of your device, please contact th of questions on the promotion and Safety at (240) 276-0484. Also, please note the VIIro Diagnostic Device Development and Sales ... (21CFR Part 807.97).
regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation entitled, "Misolanding of responsibilities under the Act from the You may other other general informations on your Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Carol C. Benem
Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
Indications for Use
| 510(k) Number (if known): | K051108 |
|---|---|
| --------------------------- | --------- |
Piccolo® Lactate Dehydrogenase Test System Device Name: _
Indications For Use:
The Piccolo Lactate Dehydrogenase Test System (presently contained on the The Piccolo Lactate Denyarogenato Treat Systems with the Piccolo Point-of-Care Precolo Basic Metabolic Panel Place Lused for the in vitro quantitative Chemilstly Analyzer 15 Interneta determination or oratory setting or point-of-care location.
Lactate dehydrogenase measurements are used in the diagnosis and treatment Lactate denydrogenase measurements and circhosis; cardiac diseases
of liver diseases such as acute viral hepatitis and cirches hart kidney, liver of liver diseases such as acute virus nopality and tissue alterations of the heart, kidney, liver, and muscle.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 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
Page 1 of
510(k) K051108