K Number
K121012
Device Name
FLEXLAB 3.6, ACCELERATOR A3600
Manufacturer
Date Cleared
2012-08-31

(150 days)

Product Code
Regulation Number
862.1600
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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. 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)
More Information

Not Found

No
The description focuses on automation of pre- and post-analytical processes, sample handling, and workload management based on predefined rules and communication protocols, without mentioning AI or ML.

No
The device is an automation system for laboratory sample processing, not a therapeutic device. It automates pre-analytical and post-analytical steps, but it does not directly treat or alleviate a medical condition.

No

The FlexLab 3.6 Automation system automates pre-analytical and post-analytical processing and sample handling. While it consolidates analytical instruments (like the ARCHITECT c8000) that perform diagnostic measurements (e.g., Sodium, Potassium, Chloride), the FlexLab 3.6 itself doesn't make the diagnosis; it prepares samples for analysis and manages workflow. Its function is to facilitate the diagnostic process, not directly perform the diagnosis.

No

The device description explicitly details hardware components and functions such as sample loading/unloading, transport, centrifugation, decapping, sealing, and storage, indicating it is a physical automation system with integrated software, not a software-only device.

Based on the provided information, the FlexLab 3.6 Automation system itself is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • Intended Use: The intended use clearly states that the system is designed to automate the processing and handling of samples in a laboratory. It facilitates the workflow around analytical instruments.
  • Device Description: The description focuses on the automation of pre-analytical and post-analytical steps, sample transport, routing, and communication with analytical instruments and LIS. It does not perform the diagnostic test itself.
  • Consolidation of Analytical Instruments: The system consolidates analytical instruments (like the ARCHITECT c8000) which do perform the IVD assays (Sodium, Potassium, Chloride). The FlexLab provides the infrastructure to support these IVD instruments.
  • Performance Studies: The performance studies compare the performance of an analytical instrument (ARCHITECT c8000) when integrated with the FlexLab versus another automation system (ACCELERATOR APS). The study is evaluating the impact of the automation system on the performance of the IVD assay, not the performance of the automation system as a diagnostic tool.

In summary, the FlexLab 3.6 Automation is a laboratory automation system that supports and integrates with IVD devices, but it does not perform the diagnostic testing itself. It is a tool for improving the efficiency and workflow of a laboratory that utilizes IVD instruments.

N/A

Intended Use / 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.

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.

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

CEM, CGZ, JGS, JJE, JQP

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)

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

Not Found

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)

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:

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Chloride
Method Comparison Data FlexLab 3.6 vs. ACCELERATOR APS 1st Replicate versus Mean - Chloride Assay - Linear Range
N: 100
Corr Coef: 0.993
Slope: 1.00 (95% CI: 0.99, 1.01)
Intercept: 0.90 (95% CI: -1.70, -0.09)
Deming Slope: 1.00 (95% CI: 0.99, 1.01)
Deming Intercept: 0.97 (95% CI: -1.65, -0.29)
Passing-Bablok Slope: 1.00 (95% CI: 0.99, 1.01)
Passing-Bablok Intercept: 0.89 (95% CI: -1.61, -0.23)
Mean Bias: -0.81
SD of Mean % Bias: 0.72
Absolute Value of % Total Error: 2.3

Method Comparison Data FlexLab 3.6 vs. ACCELERATOR APS Mean versus Mean Chloride Assay - Linear Range
N: 100
Corr Coef: 0.9997
Slope: 1.00 (95% CI: 1.00, 1.01)
Intercept: -1.13 (95% CI: -1.68, -0.58)
Deming Slope: 1.00 (95% CI: 1.00, 1.01)
Deming Intercept: -1.17 (95% CI: -1.74, -0.59)
Passing-Bablok Slope: 1.00 (95% CI: 0.99, 1.01)
Passing-Bablok Intercept: -0.91 (95% CI: -1.40, 0.28)
Mean Bias: -0.85
Mean % Bias: -0.9
SD of Mean % Bias: 0.56
Absolute Value of % Total Error: 2.0

Potassium
Method Comparison Data FlexLab 3.6 vs. ACCELERATOR APS 1st Replicate versus Mean Potassium Assay - Linear Range
N: 100
Corr Coef: 0.9995
Slope: 1.00 (95% CI: 1.00, 1.01)
Intercept: -0.06 (95% CI: -0.09, -0.03)
Deming Slope: 1.00 (95% CI: 1.00, 1.01)
Deming Intercept: -0.06 (95% CI: -0.09, -0.03)
Passing-Bablok Slope: 1.00 (95% CI: 1.00, 1.01)
Passing-Bablok Intercept: -0.05 (95% CI: -0.07, -0.02)
Mean Bias: -0.03
Mean % Bias: -0.8
SD of Mean % Bias: 1.11
Absolute Value of % Total Error: 3.0

Method Comparison Data FlexLab 3.6 vs. ACCELERATOR APS Mean versus Mean Potassium Assay - Linear Range
N: 100
Corr Coef: 0.9997
Slope: 1.00 (95% CI: 1.00, 1.01)
Intercept: -0.06 (95% CI: -0.08, -0.03)
Deming Slope: 1.00 (95% CI: 1.00, 1.01)
Deming Intercept: -0.06 (95% CI: -0.08, -0.03)
Passing-Bablok Slope: 1.00 (95% CI: 1.00, 1.01)
Passing-Bablok Intercept: -0.04 (95% CI: -0.06, -0.02)
Mean Bias: -0.04
Mean % Bias: -0.9
SD of Mean % Bias: 0.97
Absolute Value of % Total Error: 2.8

Sodium
Method Comparison Data FlexLab 3.6 vs. ACCELERATOR APS 1st Replicate versus Mean Sodium Assay - Linear Range
N: 100
Corr Coef: 0.9993
Slope: 1.01 (95% CI: 1.00, 1.02)
Intercept: -2.37
Deming Slope: 1.01 (95% CI: 1.00, 1.02)
Deming Intercept: -2.48
Passing-Bablok Slope: 1.02 (95% CI: 1.01, 1.03)
Passing-Bablok Intercept: -3.08
Mean Bias: -0.76
Mean % Bias: -0.6
SD of Mean % Bias: 0.90
Absolute Value of % Total Error: 2.4

Method Comparison Data FlexLab 3.6 vs. ACCELERATOR APS Mean versus Mean Sodium Assay - Linear Range
N: 100
Corr Coef: 0.9997
Slope: 1.01 (95% CI: 1.01, 1.02)
Intercept: -2.46 (95% CI: -3.20, -1.72)
Deming Slope: 1.01 (95% CI: 1.00, 1.02)
Deming Intercept: -2.51 (95% CI: -3.42, -1.59)
Passing-Bablok Slope: 1.01 (95% CI: 1.01, 1.02)
Passing-Bablok Intercept: -2.61 (95% CI: -3.82, -1.74)
Mean Bias: -0.87
Mean % Bias: -0.7
SD of Mean % Bias: 0.74
Absolute Value of % Total Error: 2.2

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.

K093318

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

§ 862.1600 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.

0

510 k

Summary

K|2|0|2

AUG 3 1 2012

| Submitter's name/address | Inpeco S.p.A.
Via Giuseppe di Vittorio 11
20090 Segrate, Milan, Italy |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact Person | Roberto Tamborra
Regulatory Affairs Manager
roberto.tamborra@inpeco.com
Phone number: +39 02 36681263
Mobile Phone number +39 334 6669384 |
| Secondary Contact Person | Luisa Mella
Regulatory Affairs Specialist
luisa.mella@inpeco.com
Phone number: +39 02 36681316 |
| Date of preparation of this Summary: | 2012-03-30 |
| Device Trade or Proprietary Name: | FlexLab 3.6
ACCELERATOR a3600 |
| Device Common Name: | Laboratory Automation |
| Classification Number/Class: | JQP, Class I (FlexLab 3.6 and
ACCELERATOR 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

1

Identification of Predicate Device:

| Predicate Instrument or

Assay510(k) NumberProduct Code
APS AcceleratorK093318JOP

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 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)

2

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.

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.

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.

3

| Product
Functionality | Predicate Device:
ARCHITECT c8000 with
embedded ICT Module
integrated to
ACCELERATOR APS | Test Device:
ARCHITECT c8000 with
embedded ICT Module
integrated to FlexLab 3.6 |
|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Same, with automated pre-
analytical sample processing
and transporting to the
ARCHITECT analyzer | Same, with automated pre-
analytical sample processing
and transporting to the
ARCHITECT analyzer |
| Principle of
Operation | Same | Same |
| Sample Containers | Primary or Aliquot Tubes | Primary and secondary Tubes |
| Sample Aspiration | Directly from primary tube
presented to the aspiration
point by the ACCELERATOR
APS track or spur | Directly from primary tube
presented to the aspiration
point by the FlexLab 3.6 track
or spur |
| Sample Handling | Directly loaded into the
ARCHITECT via the LSH or
via ACCELERATOR APS | Directly loaded into the
ARCHITECT via the LSH or
via FlexLab 3.6 |
| Sample Pre-
Analytics
(centrifuge, de-
cap, re-seal, re-cap,
aliquoter) | Manually centrifuged sample
tubes by laboratory personnel
or automatically centrifuged
tubes by ACCELERATOR
APS | Manually centrifuged sample
tubes by laboratory personnel
or automatically centrifuged
tubes by FlexLab 3.6 |
| | Manually de-capped sample
tubes by laboratory personnel
or automatically de-capped
tubes by ACCELERATOR
APS | Manually de-capped sample
tubes by laboratory personnel
or automatically de-capped
tubes by FlexLab 3.6 |
| | Manually re-sealed sample
tubes by laboratory personnel
or automatically re-sealed
tubes by ACCELERATOR
APS | Manually re-sealed sample
tubes by laboratory personnel
or automatically re-sealed
tubes by FlexLab 3.6 |
| | Manually aliquoted samples by
laboratory personnel or
automatically aliquoted tubes
by ACCELERATOR APS | Manually aliquoted samples by
laboratory personnel or
automatically aliquoted tubes
by |
| | Same | Same |
| | | |
| Sample | External to analyzer: by
ACCELERATOR APS
transport carriers identified on
the system by RFID tags.

Internal to analyzer: N/A,
samples presented to analyzer
via ACCELERATOR a3600
for aspiration. | External to analyzer: by
FlexLab 3.6 transport carriers
identified on the system by
RFID tags.

Internal to analyzer: N/A,
samples presented to analyzer
via FlexLab 3.6 for aspiration. |
| Sample
Identification from
bar coded tubes | Bar coded sample tubes read
directly by analyzer when
placed on LSH, or sample bar
code read by ACCELERATOR
APS and electronically
transferred to the ARCHITECT
c8000 analyzer when presented
at the aspiration point | Bar coded sample tubes read
directly by analyzer when
placed on LSH, or sample bar
code read by FlexLab 3.6 and
electronically transferred to the
ARCHITECT c8000 analyzer
when presented at the
aspiration point |
| Sample
Storage/Retrieval | Manually stored and retrieved
by laboratory personnel or
automatically stored/retrieved
by ACCELERATOR APS | Manually stored and retrieved
by laboratory personnel or
automatically stored/retrieved
by FlexLab 3.6 |
| Test Orders | Same | Same |
| Test Results | Same | Same |
| LAS
Communication | ARCHITECT software
communicates with
ACCELERATOR APS via
LAS interface | ARCHITECT software
communicates with FlexLab
3.6 via LAS interface |
| LIS
Communication | ARCHITECT software
communicates with hospital
LIS via ACCELERATOR APS
data management system
interface | ARCHITECT software
communicates with hospital
LIS via FlexLab 3.6 data
management system interface |

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

4

.

:

5

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

CILeast SquaresDemingPassing-Bablok
SlopeInterceptSlopeInterceptSlopeInterceptBias / Total Error
NCor
CoefSlope%95 CIInt95% CISlope%95 CIInt95% CISlope%95 CIInt95% CIMean
BiasSD of
Mean
% BiasAbsolute
Value
of %
Total
Error
1000.9931.00(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)-0.810.722.3

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

ClLeast SquaresDemingPassing-BablokBias / Total Error
SlopeInterceptSlopeInterceptSlopeIntercept
NCor
r
Coe
fSlope%95 CIInt95% CISlope%95 CIInt95% CISlope%95 CIInt95% CIMean BiasMean % BiasSD of Mean % BiasAbsolute Value of % Total Error
1000.9
9971.00(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)-0.85-0.90.562.0

6

Potassium

KLeast SquaresDemingPassing-BablokBias / Total Error
SlopeInterceptSlopeInterceptSlopeInterceptAbsolute
Value
of %
Total
Error
NCorr
CoefSlope%95 CIInt95% CISlope%95 CIInt95% CISlope95% CIInt95% CIMean
BiasMean
%
BiasSD of
Mean
% Bias
1000.99951.00(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)-0.03-0.81.113.0

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

KLeast SquaresDemingPassing-BablokBias / Total Error
SlopeInterceptSlopeInterceptSlopeInterceptMean BiasMean % BiasSD of Mean % BiasAbsolute Value of % Total Error
NCorr CoefSlope95% CIInt95% CISlope95% CIInt95% CISlope95% CIInt95% CI
1000.99971.00(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)-0.04-0.90.972.8

Section 5-page 8

7

Sodium

NaLeast SquaresDemingPassing-BablokBias / Total Error
SlopeInterceptSlopeInterceptSlopeInterceptAbsolute
Value
of
%
Total
Error
NCorr
CoefSlopeIntSlopeIntSlopeIntMean
BiasMean
%
BiasSD of
Mean
% Bias
1000.99
931.01
(1.00,
1.02)-
2.371.01
(1.00,
1.02)-
2.481.02
(1.01,
1.03)-
3.08-
0.76-0.60.902.4

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

NaLeast SquaresDemingPassing-BablokBias / Total Error
NSlopeInterceptSlopeInterceptSlopeInterceptMean BiasMean % BiasSD of Mean % BiasAbsolute Value of % Total Error
1000.99971.01
(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)-0.87-0.70.742.2

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.

8

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).

9

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,

V

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

10

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.

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.

Prescription UseX
(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)