Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard in vitro diagnostic device that performs chemical reactions to measure lactate concentration. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the provided text. The performance studies focus on analytical performance metrics like linearity, sensitivity, precision, and method comparison, which are standard for IVD devices and do not indicate the use of AI/ML.

Therapeutic

No.
The device is used for the in vitro quantitative determination of lactate concentration to aid in diagnosis and treatment, not to treat a condition itself.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that "Lactate measurements are used in the diagnosis and treatment of lactate acidosis, monitoring tissue hypoxia, and diagnosis of hyperlactatemia," which are diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device description clearly states it includes a "Piccolo MetLac 12 Panel Reagent Disc" which is a physical component containing reagents and designed to interact with a "Piccolo xpress™ Chemistry Analyzer". This indicates the device is not software-only.

IVD (In Vitro Diagnostic)

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 to be used for the in vitro quantitative determination of lactate concentration in heparinized whole blood or heparinized plasma". "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
Sample Type: The device analyzes biological samples (heparinized whole blood or heparinized plasma) taken from the human body.
Purpose: The measurements are used for "diagnosis and treatment of lactate acidosis, monitoring tissue hypoxia, and diagnosis of hyperlactatemia," which are clinical purposes.
Device Description: The description details how the device processes the sample and reagents to perform a chemical reaction for measurement, which is typical of an IVD.
Performance Studies: The document includes detailed performance studies (Linearity, Sensitivity, Precision, Method Comparison, Interference Studies) which are required for the regulatory approval of IVD devices.
Predicate Device: The mention of a "Predicate Device" (i-STAT Lactate/LAC) is common in regulatory submissions for IVDs, where a new device is compared to an already approved device.

All these points strongly indicate that the Piccolo® Lactate Test System is an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Piccolo® Lactate Test System (presently contained on the MetLac 12 Panel Reagent Disc) used with the Piccolo xpress™ Chemistry Analyzer is intended to be used for the in vitro quantitative determination of lactate concentration in heparinized whole blood or heparinized plasma in a clinical laboratory setting or point-of-care location.

Lactate measurements are used in the diagnosis and treatment of lactate acidosis, monitoring tissue hypoxia, and diagnosis of hyperlactatemia.

Product codes (comma separated list FDA assigned to the subject device)

KHP

Device Description

The Piccolo MetLac 12 Panel Reagent Disc (which contains the Piccolo Lactate Test System) is designed for lithium heparinized whole blood and lithium heparinized plasma. 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 sample 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: 1.00
Intercept: 0.00
Corr. Coefficient: 0.999

Sensitivity - Limits of Blank (LOB), Limits of Detection (LOD), and Limits of Quantitation (LOQ):
Study conducted according to CLSI EP17-A.
Seven pools, including the lowest non-zero lactate calibrator (normal human plasma pool 1.78 mmol/L), five dilutions of the lowest calibrator in saline, and a saline blank were assayed.
Each pool was assayed sixty times, three times on each of 20 Piccolo xpress Chemistry Analyzers on one day.
LOB: 0.02 mmol/L (determined as non-parametric 95th percentile)
LOD: 0.07 mmol/L
LOQ: 0.11 mmol/L (point at which 20% total error was determined)

Precision:
Precision studies designed to evaluate within-run and total precision.

Control and Plasma Pool Testing (Lactate in mmol/L):
- Control Level 1 (N=80): Mean 1.62, Within-Run SD 0.03, %CV 1.8; Total SD 0.04, %CV 2.2
- Control Level 2 (N=80): Mean 3.63, Within-Run SD 0.05, %CV 1.5; Total SD 0.08, %CV 2.3
- Control Level 3 (N=80): Mean 6.99, Within-Run SD 0.18, %CV 2.6; Total SD 0.36, %CV 5.2
- Human Plasma Pool 1 (N=40): Mean 0.86, Within-Run SD 0.02, %CV 1.9; Total SD 0.02, %CV 1.9
- Human Plasma Pool 2 (N=40): Mean 6.22, Within-Run SD 0.20, %CV Not listed; Total SD 0.20, %CV Not listed
Fresh Whole Blood Precision Testing at Abaxis:
- Sample 1 (n=20): Mean 1.02, SD 0.02, %CV 2.1
- Sample 2 (n=20): Mean 1.48, SD 0.03, %CV 2.2
- Sample 3* (n=20): Mean 1.37, SD 0.02, %CV 1.7
- Sample 4 (n=20): Mean 6.21, SD 0.20, %CV 3.3
- Sample 5 (n=20): Mean 7.77, SD 0.22, %CV 2.9
- Sample 6* (n=20): Mean 6.61, SD 0.18, %CV 2.8
Fresh Whole Blood Precision Testing at Three External Sites:
- Site 1: Combined (n=20 per sample):
  - WB 1: Mean 1.51, SD 0.03, %CV 2.0%
  - WB 2: Mean 4.63, SD 0.15, %CV 3.1%
  - WB 3: Mean 0.71, SD 0.02, %CV 2.7%
  - WB 4: Mean 4.15, SD 0.15, %CV 3.5%
- Site 2: Combined (n=20 per sample):
  - WB 25: Mean 1.01, SD 0.03, %CV 2.5%
  - WB 26: Mean 6.28, SD 0.24, %CV 3.9%
  - WB 27: Mean 1.10, SD 0.03, %CV 2.7%
  - WB 28: Mean 5.89, SD 0.25, %CV 4.2%
- Site 3: Combined (n=20 per sample):
  - WB 101: Mean 0.88, SD 0.03, %CV 3.8%
  - WB 102: Mean 5.89, SD 0.20, %CV 3.3%
  - WB 103: Mean 1.08, SD 0.03, %CV 3.2%
  - WB 104: Mean 7.76, SD 0.27, %CV 3.5%

Method Comparison with Predicate Device (i-STAT Lactate test):
Study conducted at an external site to assess accuracy.
Sample Size: 126 heparinized whole blood subjects.
Comparison of Piccolo xpress Chemistry Analyzer vs. i-STAT lactate test.
Piccolo Lactate Test System Mean: 2.92 mmol/L (range 0.30-9.88 mmol/L)
i-STAT Lactate Mean: 2.78 mmol/L (range 0.42-9.85 mmol/L)
Linear Regression (N=126): Slope 1.02 (95% CI: 1.01 to 1.04), Intercept 0.13 (95% CI: 0.07 to 0.19), Correlation Coefficient, R 0.996, R2 0.992, Sylx 0.19.
Deming Regression (N=126): Slope 1.03 (95% CI: 0.99 to 1.06), Intercept 0.06 (95% CI: -0.01 to 0.14), Correlation Coefficient, R 0.996, R2 0.992, Sylx 0.19.
Key Results: Good agreement between the values obtained by the Piccolo xpress Chemistry Analyzer and the i-STAT System for lactate.

Sample Type Comparison:
Study examined and compared results for heparinized whole blood and heparinized plasma.
Key Results: Heparinized whole blood and heparinized plasma comparability was established for lactate.

Interference Studies - Endogenous Substances:
Tested physiological substances using supplemented human serum pools (CLSI EP7-A2).
Interferent levels tested with two levels of lactate.
Acceptance limits: ± 10% of baseline.
Limits determined to be:

Hemolysis: 500 mg/dL
Icterus: 15 mg/dL
Lipemia: 3,000 mg/dL

Interference Studies - Exogenous Substances:
Forty-one drugs and other substances screened (Young DS, CLSI EP7-A2).
Human plasma pools prepared with lactate at 0.70 and 2.60 mmol/L.
Two substances significantly interfered:

Dopamine: 13 mg/dL - 85% dec; 0.52 mg/dL -

Regulation Number and Section

§ 862.1450 Lactic acid test system.

(a)
Identification. A lactic acid test system is a device intended to measure lactic acid in whole blood and plasma. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).(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.

Summary

0

Piccolo® LAC Test System

AAR 1 1 2013

3240 Whipple Road, Union City, CA 94587 Phone 510 . 675-6500 Fax 510 . 441-6150

Image /page/0/Picture/4 description: The image shows the word "ABAXIS" in a bold, sans-serif font. The letters are black and the background is white. A thin, black oval encircles the "XIS" portion of the word, adding a design element to the logo. The logo appears to be for a company or organization named 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.

مدتب؟ •-

The assigned 510(k) number is: K130113

1. Applicant Information:

Date Prepared:	March 4, 2013
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

2. Device Information:

Classification:	Class I- Reserved (point-of-care)
Trade Name:	Piccolo Lactate Test System

Classification Name: Lactate Test system 862.1450

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
i-STAT Lactate/LAC	Originally, i-STAT Corporation
(Princeton, NJ)
Currently, Abbott Point of Care Inc.
(Abbott Park, IL)	K982071	06/29/98

1

4. Description of the Device:

The Piccolo MetLac 12 Panel Reagent Disc (which contains the Piccolo Lactate Test System) is designed for lithium heparinized whole blood and lithium heparinized plasma. 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 sample mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer.

5. Statement of Intended Use:

The Piccolo® Lactate Test System (presently contained on the MetLac 12 Panel Reagent Disc) used with the Piccolo xpress™ Chemistry Analyzer is intended to be used for the in vitro quantitative determination of lactate concentration in heparinized whole blood or heparinized plasma 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 Lactate Test System in comparison to the legally marketed predicate device.

2

.

:

Summary of Safety and Effectiveness (continued)

Table 1:
Specification Comparison: Piccolo Lactate Test System & Predicate Device

	Piccolo xpress Chemistry Analyzer	Abbott i-STAT System K982017
Intended Use	Quantitative analysis of lactic acid	Quantitative analysis of lactic acid
Methodology	Enzymatic colorimetric assay	Enzymatic amperometric assay
Sample Type	Heparinized venous whole blood and
heparinized plasma	Arterial, venous, or capillary whole
blood (with or without heparin)
Dynamic Range	0.30 -- 9.99 mmol/L	0.30 - 20.00 mmol/L
Reagents	Dry test-specific reagent beads and
liquid diluent; reconstitution performed
by analyzer	Immobilized enzyme on a
biosensor and liquid reagents
	Active ingredients:
Lactate Oxidase (LOX)
Peroxidase (Horseradish)
4-aminoantipyrine (4-AAP)
3,5-dichloro-2-hydroxy-
benzenesulfonic acid (DHBSA)	Active ingredients:
Lactate Oxidase (LOX)
Lactate
Temperature of
Reaction	37°C	37°C
Calibration	Bar code with factory
calibrated lot specific data	i-STAT Lactate is automatically
calibrated during each analysis
cycle using lactate in the test
cartridge
Testing Environment	Professional use	Professional use
Sample Size	Approximately 100 µL	95 µL

.

3

1. Brief discussion of the clinical and nonclinical tests relied on for a determination of substantial equivalence.
  Tables 2 & 3 summarize the results of clinical and non-clinical tests performed using the Piccolo Lactate Test System.

Linearity:

Table 2: Summary of Linearity

	Lactate
Slope	1.00
Intercept	0.00
Corr. Coefficient	0.999

Sensitivity - Limits of Blank (LOB), Limits of Detection (LOD), and Limits of Quantitation (LOQ):

A sensitivity study was conducted according to CLSI EP17-A. Seven pools, including the lowest non-zero lactate calibrator (normal human plasma pool 1.78 mmol/L), five dilutions of the lowest calibrator in saline, and a saline blank were assaved.

Each pool was assayed sixty times, three times on each of 20 Piccolo xpress Chemistry Analyzers on one day. The pools were analyzed using the Piccolo lactate rate at each level and a linear regression calibration line was calculated with the slope and intercept serving as the calibration factors. The lactate concentrations were then calculated from the calibration factors.

The LOB, LOD, and LOQ were determined for the Abaxis lactate test system.

LOB - The values for the blank were found not to be Gaussian. Therefore, the LOB was determined as the non-parametric 95th percentile. This value is 0.02 mmol/L.

LOD - The values of the low level samples were found also not to be Gaussian. Hence, LOD was determined non-parametrically. The low level samples were checked to see where 5% or fewer of the observed measurements were below the LOB. The lowest sample tested had a recovered mean value of 0.068 mmol/L and its 5 percentile limit was at 0.057 which is significantly above the LOB. Hence, the LOD is 0.07 mmol/L.

LOQ – The point at which 20% total error (= %bias + 2*%CV) was determined by linear regression analysis. Based on this determination the LOQ is 0.11 mmol/L.

4

Precision:

Precision studies were designed to evaluate within-run and total precision of the Lactate Test System when run on the Piccolo xpress Chemistry Analyzer.

Table 3: Summary of Within-Run and Total Precision of Lactate Assayed on the Piccolo xpress Chemistry Analyzer: Control and Plasma Pool Testing

	Within-Run	Total
	Lactate (mmol/L)
Control Level 1 (N=80)
Mean	1.62	1.62
SD	0.03	0.04
%CV	1.8	2.2
Control Level 2 (N=80)
Mean	3.63	3.63
SD	0.05	0.08
%CV	1.5	2.3
Control Level 3 (N=80)
Mean	6.99	6.99
SD	0.18	0.36
%CV	2.6	5.2
Human Plasma Pool 1 (N = 40)
Mean	0.86	0.86
SD	0.02	0.02
%CV	1.9	1.9
Human Plasma Pool 2 (N = 40)
Mean	6.22	6.22
SD	0.20	0.20
%CV

5

.

Summary of Safety and Effectiveness (continued)

Results for Fresh Whole Blood Precision Testing at Abaxis

Table 4 Summary of Inter-assay Precision Study on Whole Blood for Lactate Assayed on the Piccolo xpress Chemistry Analyzer

Lactate (mmol/L)
	Sample 1	Sample 2	Sample 3*	Sample 4	Sample 5	Sample 6*
Mean	1.02	1.48	1.37	6.21	7.77	6.61
SD	0.02	0.03	0.02	0.20	0.22	0.18
%CV	2.1	2.2	1.7	3.3	2.9	2.8
n	20	20	20	20	20	20

*Note: Samples 1, 2, 4, & 5 were tested with one disc lot; Samples 3 & 6 were tested with a 2nd disc lot.

Results for Fresh Whole Blood Precision Testing at Three External Sites

| | WB 1
Operator 1 | WB 2
Operator 1 | WB 3
Operator 1 | WB 4
Operator 1 |
|-------|--------------------|--------------------|--------------------|--------------------|
| Mean | 1.52 | 4.67 | 0.72 | 4.13 |
| SD | 0.03 | 0.17 | 0.02 | 0.12 |
| %CV | 2.1% | 3.7% | 2.2% | 3.0% |
| Count | 10 | 10 | 10 | 10 |
| | WB 1
Operator 2 | WB 2
Operator 2 | WB 3
Operator 2 | WB 4
Operator 2 |
| Mean | 1.50 | 4.59 | 0.70 | 4.17 |
| SD | 0.02 | 0.10 | 0.02 | 0.17 |
| %CV | 1.7% | 2.3% | 2.5% | 4.1% |
| Count | 10 | 10 | 10 | 10 |
| | WB 1
Combined | WB2
Combined | WB 3
Combined | WB 4
Combined |
| Mean | 1.51 | 4.63 | 0.71 | 4.15 |
| SD | 0.03 | 0.15 | 0.02 | 0.15 |
| %CV | 2.0% | 3.1% | 2.7% | 3.5% |
| Count | 20 | 20 | 20 | 20 |

5a. Whole Blood Precision at Site 1

6

| | WB 25
Operator 1 | WB 26
Operator 1 | WB 27
Operator 1 | WB 28
Operator 1 |
|-------|---------------------|---------------------|---------------------|---------------------|
| Mean | 1.00 | 6.18 | 1.09 | 5.88 |
| SD | 0.03 | 0.21 | 0.03 | 0.32 |
| %CV | 2.8% | 3.4% | 2.6% | 5.5% |
| Count | 10 | 10 | 10 | 10 |
| | WB 25
Operator 2 | WB 26
Operator 2 | WB 27
Operator 2 | WB 28
Operator 2 |
| Mean | 1.02 | 6.38 | 1.12 | 5.90 |
| SD | 0.02 | 0.25 | 0.03 | 0.17 |
| %CV | 1.7% | 3.9% | 2.3% | 2.9% |
| Count | 10 | 10 | 10 | 10 |
| | WB 25
Combined | WB 26
Combined | WB 27
Combined | WB 28
Combined |
| Mean | 1.01 | 6.28 | 1.10 | 5.89 |
| SD | 0.03 | 0.24 | 0.03 | 0.25 |
| %CV | 2.5% | 3.9% | 2.7% | 4.2% |
| Count | 20 | 20 | 20 | 20 |

5b. Whole Blood Precision at Site 2

7

	Summary of Safety and Effectiveness (continued)
--	-------------------------------------------------	--

| | WB 101
Operator 1 | WB 102
Operator 1 | WB 103
Operator 1 | WB 104
Operator 1 |
|-------|----------------------|----------------------|----------------------|----------------------|
| Mean | 0.88 | 5.93 | 1.09 | 7.76 |
| SD | 0.03 | 0.24 | 0.03 | 0.28 |
| %CV | 3.3% | 4.1% | 3.0% | 3.7% |
| Count | 10 | 10 | 10 | 10 |
| | WB 101
Operator 2 | WB 102
Operator 2 | WB 103
Operator 2 | WB 104
Operator 2 |
| Mean | 0.88 | 5.86 | 1.06 | 7.76 |
| SD | 0.04 | 0.14 | 0.03 | 0.28 |
| %CV | 4.3% | 2.5% | 2.9% | 3.5% |
| Count | 10 | 10 | 10 | 10 |
| | WB 101
Combined | WB 102
Combined | WB 103
Combined | WB 104
Combined |
| Mean | 0.88 | 5.89 | 1.08 | 7.76 |
| SD | 0.03 | 0.20 | 0.03 | 0.27 |
| %CV | 3.8% | 3.3% | 3.2% | 3.5% |
| Count | 20 | 20 | 20 | 20 |

5c. Whole Blood Precision at Site 3

Method Comparison with Predicate Device:

The method comparison study was conducted at an external site to assess the accuracy of the Abaxis lactate method. Results obtained from the Piccolo xpress Chemistry Analyzer were compared with results obtained from the predicate device, i-STAT lactate test (Abbott), when testing aliquots of the same samples tested side-byside in singlicate.

Heparinized whole blood from 126 subjects was tested on the Piccolo xpress Chemistry Analyzer and the predicate device. A good distribution of lactate values was obtained. Each sample was run on one (1) of four (4) Piccolo xpress Chemistry Analyzers and on one (1) i-STAT analyzer.

Standard linear regression analysis was used for estimation of the slope, intercept, and correlation coefficient. Deming regression analysis was also performed. The results of these studies are shown in Table 6 below.

8

Table 6: Method Comparison Data for Lactate Assayed on the Piccolo xpress Chemistry Analyzer and the i-STAT Lactate System

Parameters	Statistics
Piccolo Lactate Test System: singlicate values	126
i-STAT Lactate: singlicate values	126
Piccolo Lactate Test System Mean	2.92 mmol/L
i-STAT Lactate Mean	2.78 mmol/L
Piccolo Lactate Test System Std. Dev.	2.04 mmol/L
i-STAT Lactate Std. Dev.	1.99 mmol/L
Piccolo Lactate Test System range of samples	0.30-9.88 mmol/L
i-STAT Lactate range of samples	0.42-9.85 mmol/L

	Linear Regression	Deming Regression
N	126	126
Slope (95% CI)	1.02 (1.01 to 1.04)	1.03 (0.99 to 1.06)
Intercept (95% CI)	0.13 (0.07 to 0.19)	0.06 (-0.01 to 0.14)
Correlation Coefficient, R	0.996	0.996
R2	0.992	0.992
Sylx (Std. Error of Estimate)	0.19	0.19

The data indicate good agreement between the values obtained by the Piccolo xpress Chemistry Analyzer and the i-STAT System for lactate.

Sample Type Comparison:

A study was conducted to examine and compare results for heparinized whole blood and heparinized plasma on the Piccolo® xpress Chemistry Analyzer.

Heparinized whole blood and heparinized plasma comparability was established for lactate.

Interference Studies - Endogenous Substances:

The interference studies for physiological substances used supplemented human serum pools to assess the effects of potential interferents on the Piccolo Lactate Test System. Plasma pools for the physical interference study were prepared according to CLSI EP7-A2. The test pools contained different levels of the potential interferent

9

under investigation. At least four (4) test pools and a control pool were prepared for each. Two levels of lactate were used in all testing.

Further, each interferent was tested at increasing levels of interfering substances. Hemoglobin interference was measured using human red blood cell hemolysate. icterus interference used a concentrate of conjugate and unconjugated bilirubin, and lipemic interference used Intralipid. Acceptance limits of ± 10% of the base line (0 interferent) were used for both levels of lactate to determine the limits. In this way the limits were determined to be: hemolysis 500 mg/dL, icterus 15 mg/dL, and lipemia 3,000 mg/dL.

Interference Studies - Exogenous Substances:

Forty-one drugs and other substances were selected as potential interferents with the lactate method based on recommendations by Young DS. Effects of drugs on clinical laboratory tests, 3rd ed. Washington, DC: AACC Press, 1990, and CLSI EP7-A2. Human plasma pools were prepared that contained lactate at 0.70 and 2.60 mmol/L.

Only two (2) substances at the concentrations listed below significantly interfered with lactate recovery. These are dopamine and L-dopa. After titration, these were found not to interfere at 0.52 (dopamine) and 0.5 (L-dopa) mg/dL.

Table 7

Substance	Concentration	% InterferenceA
Dopamine	13	85% dec
	0.52