The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory.

The system consolidates analytical instruments, such as the ARCHITECT c8000 System into a unified workstation that performs a variety of instrument specific assays such as Sodium, Potassium and Chloride.

Sodium, Potassium and Chloride measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance.

Device Description

The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory.

The system consolidates multiple Analytical instruments into a unified workstation.

The Automation software provides for workload management, sample routing to relevant Analytical instrument based on sample orders coming from LIS (Laboratory Information System) and instrument operational status monitoring. This is accomplished through communication connections between the Automation, Analytical instruments and LIS (Laboratory Information System) or middleware.

Pre-Analytical and Post-Analytical processing in details are as follows: sample loading and unloading and sample identification, sample transport along the system and routing to relevant modules, loading and unloading in centrifuge, decapping, sealing, storing in a temperature controlled environment, aliquot samples capping, sample presentation to connected Analytical instruments.

The FlexLab 3.6 Automation Systems perform the following pre and post analytical functions:

Sample bar code identification (previously performed by the analyzer) Sample transport and tracking Sample centrifugation (Optional functionality) Sample de-capping (Optional functionality) Sample re-capping (Optional functionality) Sample sealing (Optional functionality) Sample de-sealing (Optional functionality) Sample aliquoting (Optional functionality) Sample Storage and Retrieval (Optional functionality)

AI/ML Overview

The provided document describes a 510(k) submission for the FlexLab 3.6 / ACCELERATOR a3600 system, a laboratory automation system designed to automate pre-analytical and post-analytical processing and sample handling.

The study presented focuses on demonstrating substantial equivalence to an existing predicate device (APS Accelerator, K093318) rather than meeting specific performance acceptance criteria for a new clinical device. The primary aim is to show that the new system, when integrated with an ARCHITECT c8000 analyzer, produces comparable results for Sodium, Potassium, and Chloride assays as the predicate system.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a substantial equivalence study for a laboratory automation system, the "acceptance criteria" are implied to be the demonstration of comparable performance to the predicate device. The performance is measured by method comparison statistics.

Analyte	Statistical Method	Parameter	Predicate (ACCELERATOR APS) vs. Test (FlexLab 3.6) Performance (Mean vs. Mean)
Chloride	Least Squares	Slope (95% CI)	1.00 (1.00, 1.01)
		Intercept (95% CI)	-1.13 (-1.68, -0.58)
	Deming	Slope (95% CI)	1.00 (1.00, 1.01)
		Intercept (95% CI)	-1.17 (-1.74, -0.59)
	Passing-Bablok	Slope (95% CI)	1.00 (0.99, 1.01)
		Intercept (95% CI)	-0.91 (-1.40, 0.28)
	Bias / Total Error	Mean Bias	-0.85
		Mean % Bias	-0.9
		SD of Mean % Bias	0.56
		Absolute Value of % Total Error	2.0
Potassium	Least Squares	Slope (95% CI)	1.00 (1.00, 1.01)
		Intercept (95% CI)	-0.06 (-0.08, -0.03)
	Deming	Slope (95% CI)	1.00 (1.00, 1.01)
		Intercept (95% CI)	-0.06 (-0.08, -0.03)
	Passing-Bablok	Slope (95% CI)	1.00 (1.00, 1.01)
		Intercept (95% CI)	-0.04 (-0.06, -0.02)
	Bias / Total Error	Mean Bias	-0.04
		Mean % Bias	-0.9
		SD of Mean % Bias	0.97
		Absolute Value of % Total Error	2.8
Sodium	Least Squares	Slope (95% CI)	1.01 (1.01, 1.02)
		Intercept (95% CI)	-2.46 (-3.20, -1.72)
	Deming	Slope (95% CI)	1.01 (1.00, 1.02)
		Intercept (95% CI)	-2.51 (-3.42, -1.59)
	Passing-Bablok	Slope (95% CI)	1.01 (1.01, 1.02)
		Intercept (95% CI)	-2.61 (-3.82, -1.74)
	Bias / Total Error	Mean Bias	-0.87
		Mean % Bias	-0.7
		SD of Mean % Bias	0.74
		Absolute Value of % Total Error	2.2

Acceptance Criteria (Implied): For a substantial equivalence claim, the expectation is that the comparative statistics (slope, intercept, bias) demonstrate close agreement between the FlexLab 3.6 integrated system and the ACCELERATOR APS integrated system. Ideally, slopes should be close to 1, intercepts close to 0, and biases minimal, indicating no significant difference in analytical results due to the automation system change. The reported 95% Confidence Intervals for slopes generally include 1, and for intercepts, they often include 0 or are small, supporting the claim of substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Test Set): 100 samples (indicated by "N=100" in all method comparison tables for Chloride, Potassium, and Sodium).
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It describes a "Method Comparison Study" which typically involves prospective collection of samples to run on both systems simultaneously or in close sequence. The use of "individual sample tube barcode labels (SID)" suggests careful sample tracking.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This type of study (method comparison for a laboratory automation system) does not rely on "experts" to establish a ground truth in the traditional sense of clinical diagnosis. Instead, the "ground truth" is the measurement obtained from the predicate device system (ARCHITECT c8000 integrated with ACCELERATOR APS). The comparison is between two automated systems, not against a human expert interpretation or a gold standard diagnostic.

4. Adjudication Method for the Test Set

No adjudication method is relevant for this type of test. The comparison is between two objective measurement systems.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This study is about the analytical performance of an automation system in a clinical laboratory setting, not diagnostic interpretation by human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply here.

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

Yes, in a sense, this is a standalone performance comparison of the new automation system (FlexLab 3.6) against the predicate automation system (ACCELERATOR APS), both integrated with the same analytical instrument (ARCHITECT c8000). The focus is on the impact of the automation system on the analytical results.

7. The Type of Ground Truth Used

The "ground truth" for this substantial equivalence comparison is the results obtained from the predicate device system (ARCHITECT c8000 analyzer integrated with the ACCELERATOR APS). The study aims to show that the new device system yields clinical measurements that are equivalent to a legally marketed predicate device, thereby confirming its safety and effectiveness.

8. The Sample Size for the Training Set

This study describes a verification and validation study, not a machine learning model development. Therefore, there is no "training set" in the context of AI/ML. The 100 samples mentioned were for the performance comparison.

9. How the Ground Truth for the Training Set was Established

As there is no training set for an AI/ML model, this question is not applicable. The study is a direct comparison of analytical measurements between two laboratory automation systems.

Summary

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510 k

Summary

K|2|0|2

AUG 3 1 2012

Submitter's name/address	Inpeco S.p.A.Via Giuseppe di Vittorio 1120090 Segrate, Milan, Italy
Primary Contact Person	Roberto TamborraRegulatory Affairs Managerroberto.tamborra@inpeco.comPhone number: +39 02 36681263Mobile Phone number +39 334 6669384
Secondary Contact Person	Luisa MellaRegulatory Affairs Specialistluisa.mella@inpeco.comPhone number: +39 02 36681316
Date of preparation of this Summary:	2012-03-30
Device Trade or Proprietary Name:	FlexLab 3.6ACCELERATOR a3600
Device Common Name:	Laboratory Automation
Classification Number/Class:	JQP, Class I (FlexLab 3.6 andACCELERATOR a3600)JJE, Class I (ARCHITECT)JGS, CEM, CGZ, Class II (Sodium, Potassium, Chloride)

Please consider that FlexLab 3.6 and ACCELERATOR a3600 are exactly the same product, the only difference is in the brand name.

In the annexes sometimes only FlexLab 3.6 brand name is listed but all the documents are valid also for ACCELERATOR a3600 brand name. This happens because internally the project was developed under FlexLab 3.6 brand name and then the product will be sold with two different brand names: FlexLab 3.6 and ACCELERATOR a3600.

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: ___k121012

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Identification of Predicate Device:

Predicate Instrument orAssay	510(k) Number	Product Code
APS Accelerator	K093318	JOP

Description:

The following is a brief description of the FlexLab 3.6 system.

The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory.

The system consolidates multiple Analytical instruments into a unified workstation.

The FlexLab 3.6 Automation Systems perform the following pre and post analytical functions:

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Intended Use:

The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory.

Sodium, Potassium and Chloride measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance.

Substantial Equivalence:

The substantial equivalence is demonstrated through a Method Comparison Study between an ARCHITECT c8000 analyzer integrated to the FlexLab 3.6system, and an ARCHITECT c8000 analyzer integrated to an ACCELERATOR APS utilizing the same specimens uniquely labeled with individual sample tube barcode labels for sample identification (SID).

The substantial equivalence testing is conducted utilizing the ARCHITECT c8000 ICT Module for the electrolytes of Sodium, Potassium and Chloride.

The FlexLab 3.6, as an accessory to the analyzers, does not change, expand, or limit the intended use of each analyzer product.

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Table 5-1: Similarities and Difference Table to Predicate Devices

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Performance Characteristics:

The method correlation comparison study was conducted between:

. an ARCHITECT c8000 analyzer integrated with the FlexLab 3.6 system and an ARCHITECT c8000 analyzer integrated with the ACCELERATOR APS system
and yielded the following results for the Sodium, Potassium and Chloride assays:

Chloride

Method Comparison Data FlexLab 3.6 vs. ACCELERATOR APS 1st Replicate versus Mean - Chloride Assay - Linear Range

CI	Least Squares		Deming		Passing-Bablok
	Slope	Intercept	Slope	Intercept	Slope	Intercept	Bias / Total Error
N	CorCoef	Slope	%95 CI	Int	95% CI	Slope	%95 CI	Int	95% CI	Slope	%95 CI	Int	95% CI	MeanBias	SD ofMean% Bias	AbsoluteValueof %TotalError
100	0.993	1.00	(0.99,1.01)	0.90	(-1.70, -0.09)	1.00	(0.99,1.01)	0.97	(-1.65, -0.29)	1.00	(0.99,1.01)	0.89	(-1.61, -0.23)	-0.81	0.72	2.3

Method Comparison Data FlexLab 3.6 vs. ACCELERATOR APS Mean versus Mean Chloride Assay - Linear Range

Cl		Least Squares				Deming				Passing-Bablok				Bias / Total Error
		Slope	Intercept			Slope	Intercept			Slope	Intercept
N	CorrCoef	Slope	%95 CI	Int	95% CI	Slope	%95 CI	Int	95% CI	Slope	%95 CI	Int	95% CI	Mean Bias	Mean % Bias	SD of Mean % Bias	Absolute Value of % Total Error
100	0.9997	1.00	(1.00,1.01)	-1.13	(-1.68, -0.58)	1.00	(1.00,1.01)	-1.17	(-1.74, -0.59)	1.00	(0.99,1.01)	-0.91	(-1.40,0.28)	-0.85	-0.9	0.56	2.0

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Potassium

K	Least Squares		Deming		Passing-Bablok		Bias / Total Error
	Slope	Intercept	Slope	Intercept	Slope	Intercept				AbsoluteValueof %TotalError
N	CorrCoef	Slope	%95 CI	Int	95% CI	Slope	%95 CI	Int	95% CI	Slope	95% CI	Int	95% CI	MeanBias	Mean%Bias	SD ofMean% Bias
100	0.9995	1.00	(1.00,1.01)	-0.06	(-0.09, -0.03)	1.00	(1.00,1.01)	-0.06	(-0.09, -0.03)	1.00	(1.00,1.01)	-0.05	(-0.07, -0.02)	-0.03	-0.8	1.11	3.0

Method Comparison Data FlexLab 3.6 vs. ACCELERATOR APS 1st Replicate versus Mean Potassium Assay - Linear Range

Method Comparison Data FlexLab 3.6 vs. ACCELERATOR APS . Mean versus Mean Potassium Assay - Linear Range

K	Least Squares		Deming		Passing-Bablok		Bias / Total Error
	Slope	Intercept	Slope	Intercept	Slope	Intercept	Mean Bias	Mean % Bias	SD of Mean % Bias	Absolute Value of % Total Error
N	Corr Coef	Slope	95% CI	Int	95% CI	Slope	95% CI	Int	95% CI	Slope	95% CI	Int	95% CI
100	0.9997	1.00	(1.00, 1.01)	-0.06	(-0.08, -0.03)	1.00	(1.00, 1.01)	-0.06	(-0.08, -0.03)	1.00	(1.00, 1.01)	-0.04	(-0.06, -0.02)	-0.04	-0.9	0.97	2.8

Section 5-page 8

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Sodium

	Na	Least Squares		Deming		Passing-Bablok		Bias / Total Error
		Slope	Intercept	Slope	Intercept	Slope	Intercept				AbsoluteValueof%TotalError
N	CorrCoef	Slope	Int	Slope	Int	Slope	Int	MeanBias	Mean%Bias	SD ofMean% Bias
100	0.9993	1.01(1.00,1.02)	-2.37	1.01(1.00,1.02)	-2.48	1.02(1.01,1.03)	-3.08	-0.76	-0.6	0.90	2.4

Method Comparison Data FlexLab 3.6 vs. ACCELERATOR APS 1st Replicate versus Mean Sodium Assay - Linear Range

Method Comparison Data FlexLab 3.6 vs. ACCELERATOR APS Mean versus Mean Sodium Assay - Linear Range

	Na	Least Squares		Deming		Passing-Bablok		Bias / Total Error
N		Slope	Intercept	Slope	Intercept	Slope	Intercept	Mean Bias	Mean % Bias	SD of Mean % Bias	Absolute Value of % Total Error
100	0.9997	1.01(1.01, 1.02)	-2.46(-3.20, -1.72)	1.01(1.00, 1.02)	-2.51(-3.42, -1.59)	1.01(1.01, 1.02)	-2.61(-3.82, -1.74)	-0.87	-0.7	0.74	2.2

Conclusion:

The data demonstrate that the performance of an ARCHITECT c8000 integrated with a FlexLab 3.6 LAS and an ARCHITECT c8000 integrated with an ACCELERATOR APS LAS are substantial equivalent.

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Image /page/8/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with outstretched wings.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

Inpeco, S.p.a. c/o Roberto Tamborra 11Via Giuseppe Di Vittorio Segrate, Milan, 20090 Italy

AUG 3 1 2012

K121012 Re:

Trade Name: FlexLab 3.6 Regulation Number: 21 CFR §862.1600 Regulation Name: Potassium test system Regulatory Class: Class II Product Codes: CEM, CGZ, JGS, JJE, JQP Dated: August 31, 2012 Received: August 31, 2012

Dear Mr. Tamborra:

We have reviewed your Section 510(k) premarket notification of intent to market the device We liave reviewed your Section 310(1) procession is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in
indications for use stated in the enclosure) to legally marketed in the Madige] indications for use stated in the cholosaro, we enactment date of the Medical Device interstate connitelice prior to thay 20, 1970, the vice provisions with the provisions of Amendments, or to devices that have been rockers to do not require approval of a premaint the Federal Food, Drug, and Cosment 7 to: (r. c. c. c. c. c. c. c. c. c. c. c. c. c. c. c. c. c. c. c. c. c. c. c. c. c. c. c. c. c. c. c. c. c. . c. . c. . c. . c. . c. . c. approval application (1 MX). "Tou 112), "Tou 1123, provisions of the Act include confors provisions of the Act. The genting 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 ( If your device is classified (sec above) into controls. Existing major regulations affecting (PMA), it may be subject to such additional Controllations (CFR), Parts 800 to 895.
your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 800 your device can be found in Thic 21, Code of Fouring - (1) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s issuance of a subscribes with other requirements
mean that FDA has made a determination that your device bust has begines mean that FDA has made a decemmanon maily in a ministered by other Federal agencies.
of the Act or any Federal statutes and regulations and restlight of the Act or any rederal statues and reginations annualing, but not limited to: registration
You must comply with all the Act step of and 801 on 800; medical device You must comply with an the Act Siequirements 801 and 809); medical device
and iisting (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and go and listing (21 CFR Part 807), labeling (21 Or 2016) (21 CFR 803); and good
reporting (reporting of medical device-related at the suctems (QS) regulation reporting (reporting of medical device-related durvers of each (21) regulation (21 CFR Part 820).

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire 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 productions the regarding postmarket surveillance, please contact CDRH 3 Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) Office of But vemance and Droilier 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 Tou may 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/ResourcesforYou/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

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Indications for use statement

510(k) Number (if known): K121012

Device Name: FlexLab 3.6

Indications for Use:

The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory.

Sodium, Potassium and Chloride measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance.

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 OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Yung Chan

Division Sign-Q Office of In Vitro Diagnostic Device Evaluation and Safety 510(k)

Regulation Number and Section

§ 862.1600 Potassium test system.

(a)
Identification. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.(b)
Classification. Class II.

ProductFunctionality	Predicate Device:ARCHITECT c8000 withembedded ICT Moduleintegrated toACCELERATOR APS	Test Device:ARCHITECT c8000 withembedded ICT Moduleintegrated to FlexLab 3.6
Intended Use	Same, with automated pre-analytical sample processingand transporting to theARCHITECT analyzer	Same, with automated pre-analytical sample processingand transporting to theARCHITECT analyzer
Principle ofOperation	Same	Same
Sample Containers	Primary or Aliquot Tubes	Primary and secondary Tubes
Sample Aspiration	Directly from primary tubepresented to the aspirationpoint by the ACCELERATORAPS track or spur	Directly from primary tubepresented to the aspirationpoint by the FlexLab 3.6 trackor spur
Sample Handling	Directly loaded into theARCHITECT via the LSH orvia ACCELERATOR APS	Directly loaded into theARCHITECT via the LSH orvia FlexLab 3.6
Sample Pre-Analytics(centrifuge, de-cap, re-seal, re-cap,aliquoter)	Manually centrifuged sampletubes by laboratory personnelor automatically centrifugedtubes by ACCELERATORAPS	Manually centrifuged sampletubes by laboratory personnelor automatically centrifugedtubes by FlexLab 3.6
	Manually de-capped sampletubes by laboratory personnelor automatically de-cappedtubes by ACCELERATORAPS	Manually de-capped sampletubes by laboratory personnelor automatically de-cappedtubes by FlexLab 3.6
	Manually re-sealed sampletubes by laboratory personnelor automatically re-sealedtubes by ACCELERATORAPS	Manually re-sealed sampletubes by laboratory personnelor automatically re-sealedtubes by FlexLab 3.6
	Manually aliquoted samples bylaboratory personnel orautomatically aliquoted tubesby ACCELERATOR APS	Manually aliquoted samples bylaboratory personnel orautomatically aliquoted tubesby
	Same	Same

Sample	External to analyzer: byACCELERATOR APStransport carriers identified onthe system by RFID tags.Internal to analyzer: N/A,samples presented to analyzervia ACCELERATOR a3600for aspiration.	External to analyzer: byFlexLab 3.6 transport carriersidentified on the system byRFID tags.Internal to analyzer: N/A,samples presented to analyzervia FlexLab 3.6 for aspiration.
SampleIdentification frombar coded tubes	Bar coded sample tubes readdirectly by analyzer whenplaced on LSH, or sample barcode read by ACCELERATORAPS and electronicallytransferred to the ARCHITECTc8000 analyzer when presentedat the aspiration point	Bar coded sample tubes readdirectly by analyzer whenplaced on LSH, or sample barcode read by FlexLab 3.6 andelectronically transferred to theARCHITECT c8000 analyzerwhen presented at theaspiration point
SampleStorage/Retrieval	Manually stored and retrievedby laboratory personnel orautomatically stored/retrievedby ACCELERATOR APS	Manually stored and retrievedby laboratory personnel orautomatically stored/retrievedby FlexLab 3.6
Test Orders	Same	Same
Test Results	Same	Same
LASCommunication	ARCHITECT softwarecommunicates withACCELERATOR APS viaLAS interface	ARCHITECT softwarecommunicates with FlexLab3.6 via LAS interface
LISCommunication	ARCHITECT softwarecommunicates with hospitalLIS via ACCELERATOR APSdata management systeminterface	ARCHITECT softwarecommunicates with hospitalLIS via FlexLab 3.6 datamanagement system interface