FLEXLAB 3.6, ACCELERATOR A3600

K121012 · Inpeco S.P.A. · CEM · Aug 31, 2012 · Clinical Chemistry

Device Facts

• Record ID: K121012
• Device Name: FLEXLAB 3.6, ACCELERATOR A3600
• Applicant: Inpeco S.P.A.
• Product Code: CEM · Clinical Chemistry
• Decision Date: Aug 31, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1600
• Device Class: Class 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 c8000System 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 use only

Device Story

FlexLab 3.6 is a modular laboratory automation system; integrates multiple analytical instruments into unified workstation. Inputs: barcoded sample tubes. Operations: automated sample loading/unloading, transport, centrifugation, de-capping/re-sealing, aliquoting, and storage. System reads barcodes; electronically transmits sample ID to connected analyzers (e.g., ARCHITECT c8000). Used in clinical laboratories; operated by lab personnel. Output: processed samples presented to analyzer aspiration point; automated workload management and routing based on LIS orders. Benefits: reduces manual handling; improves workflow efficiency; ensures accurate sample identification and routing.

Clinical Evidence

Bench testing only. Method comparison study performed using 100 specimens comparing ARCHITECT c8000 with FlexLab 3.6 versus ARCHITECT c8000 with ACCELERATOR APS. Results showed high correlation (r > 0.999) for Sodium, Potassium, and Chloride assays. Mean % bias ranged from -0.6% to -0.8%. Functional testing validated barcode reading and data transmission accuracy.

Technological Characteristics

Modular laboratory automation system; utilizes RFID tags for sample tracking; interfaces with LIS and analytical instruments via LAS interface; supports primary and secondary tube handling; performs automated centrifugation, decapping, re-capping, sealing, and aliquoting. Connectivity via standard laboratory automation communication protocols.

Indications for Use

Indicated for use in clinical laboratories to automate pre- and post-analytical sample processing and handling for electrolyte (Sodium, Potassium, Chloride) testing in patients requiring diagnosis or treatment of electrolyte imbalance.

Regulatory Classification

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.

Predicate Devices

• APS Accelerator (k093318)

Submission Summary (Full Text)

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510 k

# Summary

K|2|0|2

AUG 3 1 2012

| Submitter's name/address | Inpeco S.p.A.<br>Via Giuseppe di Vittorio 11<br>20090 Segrate, Milan, Italy |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact Person | Roberto Tamborra<br>Regulatory Affairs Manager<br>[e-mail]<br>Phone number: [phone]<br>Mobile Phone number [phone] |
| Secondary Contact Person | Luisa Mella<br>Regulatory Affairs Specialist<br>[e-mail]<br>Phone number: [phone] |
| Date of preparation of this Summary: | 2012-03-30 |
| Device Trade or Proprietary Name: | FlexLab 3.6<br>ACCELERATOR a3600 |
| Device Common Name: | Laboratory Automation |
| Classification Number/Class: | JQP, Class I (FlexLab 3.6 and<br>ACCELERATOR a3600)<br>JJE, Class I (ARCHITECT)<br>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 or<br>Assay | 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 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)

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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.

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.

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| Product<br>Functionality | Predicate Device:<br>ARCHITECT c8000 with<br>embedded ICT Module<br>integrated to<br>ACCELERATOR APS | Test Device:<br>ARCHITECT c8000 with<br>embedded ICT Module<br>integrated to FlexLab 3.6 |
|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Same, with automated pre-<br>analytical sample processing<br>and transporting to the<br>ARCHITECT analyzer | Same, with automated pre-<br>analytical sample processing<br>and transporting to the<br>ARCHITECT analyzer |
| Principle of<br>Operation | Same | Same |
| Sample Containers | Primary or Aliquot Tubes | Primary and secondary Tubes |
| Sample Aspiration | Directly from primary tube<br>presented to the aspiration<br>point by the ACCELERATOR<br>APS track or spur | Directly from primary tube<br>presented to the aspiration<br>point by the FlexLab 3.6 track<br>or spur |
| Sample Handling | Directly loaded into the<br>ARCHITECT via the LSH or<br>via ACCELERATOR APS | Directly loaded into the<br>ARCHITECT via the LSH or<br>via FlexLab 3.6 |
| Sample Pre-<br>Analytics<br>(centrifuge, de-<br>cap, re-seal, re-cap,<br>aliquoter) | Manually centrifuged sample<br>tubes by laboratory personnel<br>or automatically centrifuged<br>tubes by ACCELERATOR<br>APS | Manually centrifuged sample<br>tubes by laboratory personnel<br>or automatically centrifuged<br>tubes by FlexLab 3.6 |
| | Manually de-capped sample<br>tubes by laboratory personnel<br>or automatically de-capped<br>tubes by ACCELERATOR<br>APS | Manually de-capped sample<br>tubes by laboratory personnel<br>or automatically de-capped<br>tubes by FlexLab 3.6 |
| | Manually re-sealed sample<br>tubes by laboratory personnel<br>or automatically re-sealed<br>tubes by ACCELERATOR<br>APS | Manually re-sealed sample<br>tubes by laboratory personnel<br>or automatically re-sealed<br>tubes by FlexLab 3.6 |
| | Manually aliquoted samples by<br>laboratory personnel or<br>automatically aliquoted tubes<br>by ACCELERATOR APS | Manually aliquoted samples by<br>laboratory personnel or<br>automatically aliquoted tubes<br>by |
| | Same | Same |
| | | |
| Sample | External to analyzer: by<br>ACCELERATOR APS<br>transport carriers identified on<br>the system by RFID tags.<br><br>Internal to analyzer: N/A,<br>samples presented to analyzer<br>via ACCELERATOR a3600<br>for aspiration. | External to analyzer: by<br>FlexLab 3.6 transport carriers<br>identified on the system by<br>RFID tags.<br><br>Internal to analyzer: N/A,<br>samples presented to analyzer<br>via FlexLab 3.6 for aspiration. |
| Sample<br>Identification from<br>bar coded tubes | Bar coded sample tubes read<br>directly by analyzer when<br>placed on LSH, or sample bar<br>code read by ACCELERATOR<br>APS and electronically<br>transferred to the ARCHITECT<br>c8000 analyzer when presented<br>at the aspiration point | Bar coded sample tubes read<br>directly by analyzer when<br>placed on LSH, or sample bar<br>code read by FlexLab 3.6 and<br>electronically transferred to the<br>ARCHITECT c8000 analyzer<br>when presented at the<br>aspiration point |
| Sample<br>Storage/Retrieval | Manually stored and retrieved<br>by laboratory personnel or<br>automatically stored/retrieved<br>by ACCELERATOR APS | Manually stored and retrieved<br>by laboratory personnel or<br>automatically stored/retrieved<br>by FlexLab 3.6 |
| Test Orders | Same | Same |
| Test Results | Same | Same |
| LAS<br>Communication | ARCHITECT software<br>communicates with<br>ACCELERATOR APS via<br>LAS interface | ARCHITECT software<br>communicates with FlexLab<br>3.6 via LAS interface |
| LIS<br>Communication | ARCHITECT software<br>communicates with hospital<br>LIS via ACCELERATOR APS<br>data management system<br>interface | ARCHITECT software<br>communicates with hospital<br>LIS via FlexLab 3.6 data<br>management system interface |

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

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:

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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 | Cor<br>Coef | Slope | %95 CI | Int | 95% CI | Slope | %95 CI | Int | 95% CI | Slope | %95 CI | Int | 95% CI | Mean<br>Bias | SD of<br>Mean<br>% Bias | Absolute<br>Value<br>of %<br>Total<br>Error |
| 100 | 0.993 | 1.00 | (0.99,<br>1.01) | 0.90 | (-1.70, -<br>0.09) | 1.00 | (0.99,<br>1.01) | 0.97 | (-1.65, -<br>0.29) | 1.00 | (0.99,<br>1.01) | 0.89 | (-1.61, -<br>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 | Cor<br>r<br>Coe<br>f | 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 | 0.9<br>997 | 1.00 | (1.00,<br>1.01) | -1.13 | (-1.68, -<br>0.58) | 1.00 | (1.00,<br>1.01) | -1.17 | (-1.74, -<br>0.59) | 1.00 | (0.99,<br>1.01) | -0.91 | (-1.40,<br>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 | | | | Absolute<br>Value<br>of %<br>Total<br>Error | | | | | | | |
| N | Corr<br>Coef | Slope | %95 CI | Int | 95% CI | Slope | %95 CI | Int | 95% CI | Slope | 95% CI | Int | 95% CI | Mean<br>Bias | Mean<br>%<br>Bias | SD of<br>Mean<br>% Bias | |
| 100 | 0.9995 | 1.00 | (1.00,<br>1.01) | -0.06 | (-0.09, -<br>0.03) | 1.00 | (1.00,<br>1.01) | -0.06 | (-0.09, -<br>0.03) | 1.00 | (1.00,<br>1.01) | -0.05 | (-0.07, -<br>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 |

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Section 5-page 8

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#### Sodium

| | Na | Least Squares | | Deming | | Passing-Bablok | | Bias / Total Error | | | |
|-----|--------------|-------------------------|-----------|-------------------------|-----------|-------------------------|-----------|--------------------|-------------------|-------------------------|------------------------------------------------|
| | | Slope | Intercept | Slope | Intercept | Slope | Intercept | | | | Absolute<br>Value<br>of<br>%<br>Total<br>Error |
| N | Corr<br>Coef | Slope | Int | Slope | Int | Slope | Int | Mean<br>Bias | Mean<br>%<br>Bias | SD of<br>Mean<br>% Bias | |
| 100 | 0.99<br>93 | 1.01<br>(1.00,<br>1.02) | -<br>2.37 | 1.01<br>(1.00,<br>1.02) | -<br>2.48 | 1.02<br>(1.01,<br>1.03) | -<br>3.08 | -<br>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<br>(1.01, 1.02) | -2.46<br>(-3.20, -1.72) | 1.01<br>(1.00, 1.02) | -2.51<br>(-3.42, -1.59) | 1.01<br>(1.01, 1.02) | -2.61<br>(-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 [phone]. 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 [phone] or [phone] 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

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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.

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 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)