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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Piccolo® LAC Test System, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria are generally inferred from the "Summary of Safety and Effectiveness" document, which aims to demonstrate substantial equivalence to a predicate device. For each performance characteristic, the "reported device performance" is the result demonstrated by the Piccolo Lactate Test System.

Acceptance Criteria	Reported Device Performance (Piccolo Lactate Test System)	Study/Method Used
Linearity	Slope: 1.00	Linearity Study
	Intercept: 0.00
	Correlation Coefficient: 0.999
Sensitivity	LOB (Limit of Blank): 0.02 mmol/L	CLSI EP17-A study
	LOD (Limit of Detection): 0.07 mmol/L
	LOQ (Limit of Quantitation): 0.11 mmol/L
Precision	Within-Run & Total Precision (Control & Plasma Pool Testing)	Precision Studies
Control Level 1:	Mean: 1.62 mmol/L, SD: 0.03 mmol/L, %CV: 1.8 (Within-Run)
	Mean: 1.62 mmol/L, SD: 0.04 mmol/L, %CV: 2.2 (Total)
Control Level 2:	Mean: 3.63 mmol/L, SD: 0.05 mmol/L, %CV: 1.5 (Within-Run)
	Mean: 3.63 mmol/L, SD: 0.08 mmol/L, %CV: 2.3 (Total)
Control Level 3:	Mean: 6.99 mmol/L, SD: 0.18 mmol/L, %CV: 2.6 (Within-Run)
	Mean: 6.99 mmol/L, SD: 0.36 mmol/L, %CV: 5.2 (Total)
Plasma Pool 1:	Mean: 0.86 mmol/L, SD: 0.02 mmol/L, %CV: 1.9 (Within-Run)
	Mean: 0.86 mmol/L, SD: 0.02 mmol/L, %CV: 1.9 (Total)
Plasma Pool 2:	Mean: 6.22 mmol/L, SD: 0.20 mmol/L, %CV: N/A (Within-Run)
Precision (Fresh Whole Blood) - Internal	%CV ranges from 1.7% to 3.3% across 6 samples.	Inter-assay Precision Study
Precision (Fresh Whole Blood) - External	Site 1 Combined %CV: 2.0-3.5%	Whole Blood Precision Study at Three External Sites
	Site 2 Combined %CV: 2.5-4.2%
	Site 3 Combined %CV: 3.2-3.8%
Method Comparison with Predicate Device (i-STAT)	Slope (Linear Regression): 1.02 (95% CI: 1.01 to 1.04)	Method Comparison Study
	Intercept (Linear Regression): 0.13 (95% CI: 0.07 to 0.19)
	Correlation Coefficient, R: 0.996
	Slope (Deming Regression): 1.03 (95% CI: 0.99 to 1.06)
	Intercept (Deming Regression): 0.06 (95% CI: -0.01 to 0.14)
Interference (Endogenous Substances)	Hemolysis: No interference up to 500 mg/dL	Interference Studies
	Icterus: No interference up to 15 mg/dL
	Lipemia: No interference up to 3,000 mg/dL
Interference (Exogenous Substances)	Dopamine: No interference at 0.52 mg/dL	Interference Studies
	L-dopa: No interference at 0.5 mg/dL
Reference Interval	0.53 - 2.10 mmol/L (95% of values)	Reference Interval Determination

Study Details

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Linearity Study: Seven pools (including a saline blank and lowest non-zero calibrator and its dilutions). Each pool assayed 60 times.
Precision (Control and Plasma Pool Testing): 80 replicates for each Control Level (N=80), 40 replicates for each Plasma Pool (N=40). Data provenance not specified directly but implied to be internal (Abaxis) based on the context.
Precision (Fresh Whole Blood - Internal): 20 replicates for each of the 6 samples (N=20 for each). Data provenance is internal (Abaxis).
Precision (Fresh Whole Blood - External): For each of the three external sites, 4 whole blood samples were tested. Each sample was tested by 2 operators (10 replicates each), totaling 20 replicates (N=20 combined) per sample per site. Total samples across 3 sites: 12. Total tests: over 240. Data provenance is implied to be external study sites but the country is not specified.
Method Comparison with Predicate Device: 126 heparinized whole blood samples from 126 subjects. Data provenance is an external site, country not specified.
Interference Studies: For endogenous substances, multiple test pools (at least 4) and a control pool were prepared for each of the two lactate levels. For exogenous substances, human plasma pools contained lactate at 0.70 and 2.60 mmol/L. "Two levels of lactate were used in all testing." Data provenance not specified.
Reference Interval Determination: 130 heparinized whole blood samples from apparently healthy (self-reported) individuals. Data provenance not specified.

All studies appear to be prospective in nature, as they involve testing samples specifically for the purpose of validating the device. The country of origin of the data is not explicitly stated, but the company (Abaxis, Inc.) is based in Union City, CA, USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

No "experts" in the traditional sense (e.g., radiologists, pathologists) were used to establish ground truth for the test set in this context. The studies involve analytical performance.
For the Method Comparison Study, the "ground truth" or reference was the predicate device, the i-STAT Lactate test (Abbott). This device is an already legally marketed and established lactate testing system.
For other studies (linearity, precision, sensitivity, interference), the "ground truth" is defined by the known concentrations of calibrators, controls, and spiked samples, or by established laboratory reference methods and protocols (e.g., CLSI guidelines).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

None of the described studies utilize an adjudication method involving multiple human readers, as these are in vitro diagnostic device performance studies, not image interpretation or clinical decision-making studies. The performance is assessed against quantitative analytical targets or a reference device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. This device is an in vitro diagnostic instrument, not an AI-assisted diagnostic tool that helps human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance assessment was done. The entire submission describes the analytical performance of the Piccolo Lactate Test System, which is an automated instrument, functioning as a "standalone" device to measure lactate concentrations. The "human-in-the-loop" component primarily relates to sample collection, loading, and interpreting the final quantitative result.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Known concentrations / Reference Method:
- Linearity, Sensitivity, Precision, Interference: Ground truth was established by using calibrators, controls, and spiked samples with known concentrations of lactate or interferents, according to industry standards (e.g., CLSI guidelines).
- Method Comparison: The predicate device, i-STAT Lactate test (Abbott), served as the reference method for comparison.
- Reference Interval Determination: The interval was determined by testing samples from a population of "apparently healthy" individuals, and the ground truth for their health status was based on "self-reported" information.

8. The sample size for the training set

The document does not explicitly describe a "training set" in the context of machine learning or AI models. This device is an in vitro diagnostic device based on enzymatic colorimetric assay methodology.
However, if by "training set" we consider the data used to initially develop and optimize the assay and its performance characteristics (e.g., establishing reagent concentrations, reaction kinetics, calibration algorithms), this information is not detailed in the 510(k) summary. The document focuses on the validation of the final device.

9. How the ground truth for the training set was established

As noted above, a "training set" as understood in AI/ML is not applicable here. The development and optimization of such a diagnostic assay would typically involve extensive laboratory work to establish optimal reagent concentrations, reaction conditions, and calibration curves. The ground truth for this initial development would come from known standard solutions, reference methods, and clinical samples whose lactate concentrations are reliably determined by established laboratory techniques.

Summary

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

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4. Description of the Device:

5. Statement of Intended Use:

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.

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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 andheparinized plasma	Arterial, venous, or capillary wholeblood (with or without heparin)
Dynamic Range	0.30 -- 9.99 mmol/L	0.30 - 20.00 mmol/L
Reagents	Dry test-specific reagent beads andliquid diluent; reconstitution performedby analyzer	Immobilized enzyme on abiosensor 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 ofReaction	37°C	37°C
Calibration	Bar code with factorycalibrated lot specific data	i-STAT Lactate is automaticallycalibrated during each analysiscycle using lactate in the testcartridge
Testing Environment	Professional use	Professional use
Sample Size	Approximately 100 µL	95 µL

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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.

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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

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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 1Operator 1	WB 2Operator 1	WB 3Operator 1	WB 4Operator 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 1Operator 2	WB 2Operator 2	WB 3Operator 2	WB 4Operator 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 1Combined	WB2Combined	WB 3Combined	WB 4Combined
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

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	WB 25Operator 1	WB 26Operator 1	WB 27Operator 1	WB 28Operator 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 25Operator 2	WB 26Operator 2	WB 27Operator 2	WB 28Operator 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 25Combined	WB 26Combined	WB 27Combined	WB 28Combined
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

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

	WB 101Operator 1	WB 102Operator 1	WB 103Operator 1	WB 104Operator 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 101Operator 2	WB 102Operator 2	WB 103Operator 2	WB 104Operator 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 101Combined	WB 102Combined	WB 103Combined	WB 104Combined
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.

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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

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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	<10% dec
L-dopa	5	49% dec
	0.5	<10% dec

Exogenous Substances that Interfered with the Lactate Test

A dec = decrease

Reference Interval Determination:

The reference interval for the Piccolo Lactate Test System was determined in accordance with CLSI C28-A3C by testing 130 heparinized whole blood samples from apparently healthy (self-reported) individuals. The interval was defined by the limits of the central 95% of values tested and was determined to be 0.53 - 2.10 mmol/L.

8. Conclusions

The clinical and non-clinical tests performed for lactate, 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 device identified above.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/10/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and three wavy lines below the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 11. 2013

Abaxis, Inc. c/o Dennis Bleile, PhD 3240 Whipple Rd. Union City, CA 94587

Re: K130113

Trade/Device Name: Piccolo® Lactate Test System Regulation Number: 21 CFR § 862.1450 Regulation Name: Lactic acid test system Regulatory Class: I, meets limitations of exemptions per 21 CFR § 862.9 (c)(9) Product Code: KHP Dated: January 14, 2013 Received: January 22, 2013

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2— Dennis Bleile

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

CarolC.Benson-S for

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

510(k) Number (if known):

Piccolo® Lactate Test System Device Name:

Intended Use:

Indications for Use:

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

Prescription Use X (Part 21 CFR 801 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 Diagnostics and Radiological Health (OIR) Yung William -S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

K130113 510(k)

Page 1 of 1

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.