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

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 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) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY INSTRUMENT ONLY TEMPLATE

A. 510(k) Number:
k121012

B. Purpose for Submission:
The submission is to obtain clearance for FlexLab 3.6 as an accessory to clinical laboratory analyzers such as ARCHITECT c8000 analyzer. The manufacturer uses the ARCHITECT c8000 to demonstrate FlexLab 3.6 barcode sample ID transmission to the analyzer and analytical equivalence to manual sample introduction versus automated sample introduction on the analyzer.

C. Manufacturer and Instrument Name:
Inpeco, FlexLab 3.6 (distributed as: Abbott Laboratories ACCELERATOR a3600)

D. Type of Test or Tests Performed:
Quantitative, ion selective electrode (ISE)

E. System Descriptions:
1. 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 that communicates with Hospital information System (HIS).

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 or middleware.

Pre-analytical and post-analytical processing are as follows: sample loading and unloading and sample identification by barcode read (previously done by the analyzer), sample transport along the system and routing to relevant modules, loading and unloading in centrifuge, de-capping, sealing, de-sealing, storing in a

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temperature controlled environment, aliquoting, aliquot sample capping, and sample presentation to connected analytical instruments.

2. Principles of Operation:

Ion selective electrode (ISE) using potentiometry

3. Modes of Operation:

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 or middleware.

4. Specimen Identification:

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

5. Specimen Sampling and Handling:

The analyzer interface module provides the path required to move sample tubes to the analyzer and directly loaded into the ARCHITECT via the LSH or via FlexLab 3.6 Sampling takes place directly from the primary tube presented to the aspiration point by the FlexLab 3.6 track or spur.

6. Calibration:

- Provided in k093318

7. Quality Control:

- Provided in k093318

8. Software:

FDA has reviewed applicant's Hazard Analysis and Software Development processes for this line of product types:

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Yes ☐ X or No ☐

## F. Regulatory Information:

| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JJE – Analyzer, chemistry (photometric, discrete), for clinical use | Class I | 21 CFR § 862.2160 | Clinical Chemistry (75) |
| JQP – Calculator/data processing module, for clinical use | Class I | 21 CFR § 862.2100 | Clinical Chemistry (75) |
| CEM – Potassium test system | Class II | 21 CFR § 862.1600 | Clinical Chemistry (75) |
| CGZ – Chloride test system | Class II | 21 CFR § 862.1170 | Clinical Chemistry (75) |
| JGS – Sodium test system | Class II | 21 CFR § 862.1665 | Clinical Chemistry (75) |

## G. Intended Use:

1. Indication(s) 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 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.

2. Special Conditions for Use Statement(s):

Prescription use only

## H. Substantial Equivalence Information:

1. Predicate Device Name(s) and 510(k) numbers:

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APS Accelerator - k093318 (CEM)

2. Comparison with Predicate Device:

| Item | Device | Predicate: ARCHITECT c8000 with embedded ICT Module integrated to ACCELERATOR APS |
| --- | --- | --- |
| 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. | Same |
| Principle of Operation | ARCHITECT c8000 Systems utilize photometric and potentiometric technology for analyte detection | Same |
| Sample Containers | Primary and secondary tubes | Same |
| Sample Handling | Directly loaded into the ARCHITECT via the LSH or via FlexLab 3.6 | Same |
| Sample Pre-Analytics (centrifuge, de-cap, re-seal, aliquoter) | Sample tubes are centrifuged, de-capped, re-sealed, and aliquoted manually by laboratory personnel or automatically by FlexLab 3.6 | Same |
| Sample Pre-Analytics (re-cap) | Sample tubes are re-capped manually by laboratory personnel | Same |

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| Item | Device | Predicate: ARCHITECT c8000 with embedded ICT Module integrated to ACCELERATOR APS |
| --- | --- | --- |
| Sample Transportation | External to analyzer: by FlexLab 3.6 transport carriers identified on the system by RFID tagsInternal to analyzer: N/A, sample presented to analyzer via FlexLab 3.6 for aspiration. | External to analyzer: SameInternal to analyzer: Same |
| Sample Identification from bar coded tubes | 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 | Same |
| Sample Storage/Retrieval | Manually stored and retrieved by laboratory personnel or automatically stored/retrieved by FlexLab 3.6 | Same |
| Test Orders | Unidirectional from Laboratory Information System (LIS) or middle ware to analyzer | Same |
| Test Results | Unidirectional from Laboratory Information System (LIS) or middle ware to analyzer | Same |
| LAS Communication | ARCHITECT software communicates with FlexLab 3.6 via LAS interface | Same |
| LIS Communication | ARCHITECT software communicates with hospital LIS via FlexLab 3.6 data management system interface | Same |

# I. Special Control/Guidance Document Referenced (if applicable):

Safety requirements for electrical equipment for measurement, control, and laboratory use. UL61010-1:2001 (2 $^{\text{nd}}$ edition)

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J. Performance Characteristics:

1. Analytical Performance:
a. Accuracy:
- Provided in k093318
b. Precision/Reproducibility:
- Provided in k093318
c. Linearity:
- Provided in k093318
d. Carryover:
- Not applicable
e. Interfering Substances:
- Not applicable

2. Other Supportive Instrument Performance Data Not Covered Above:

Comparison studies:
a. Method comparison with predicate device:
The method correlation comparison study was conducted between an ARCHITECT c8000 analyzer with FlexLab 3.6 and an ARCHITECT c8000 analyzer with ACCERLERATOR APS yielded the following results for the Sodium, Potassium and Chloride assays.

Chloride:

| Regression Method | Number of Specimens | Correlation Coefficient | Slope (95% CI) | Y-axis Intercept (95% CI) | Mean % Bias |
| --- | --- | --- | --- | --- | --- |
| Least Squares | 100 | 0.9993 | 1.00 (0.99, 1.01) | - 0.90 (-1.70, - 0.09) | -0.8 |
| Deming | 100 | 0.9993 | 1.00 (0.99, 1.01) | - 0.97 (-1.65, -0.29) | |
| Passing-Bablok | 100 | 0.9993 | 1.00 (0.99, 1.01) | - 0.89 (-1.61, -0.23) | |

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Potassium:

| Regression Method | Number of Specimens | Correlation Coefficient | Slope (95% CI) | Y-axis Intercept (95% CI) | Mean % Bias |
| --- | --- | --- | --- | --- | --- |
| Least Squares | 100 | 0.9995 | 1.00 (1.00, 1.01) | -0.06 (-0.09, -0.03) | -0.8 |
| Deming | 100 | 0.9995 | 1.00 (1.00, 1.01) | -0.06 (-0.09, -0.03) | |
| Passing-Bablok | 100 | 0.9995 | 1.00 (1.00, 1.01) | -0.05 (-0.07, -0.02) | |

Sodium:

| Regression Method | Number of Specimens | Correlation Coefficient | Slope (95% CI) | Y-axis Intercept (95% CI) | Mean % Bias |
| --- | --- | --- | --- | --- | --- |
| Least Squares | 100 | 0.9993 | 1.01 (1.00, 1.02) | -2.37 (-3.50, -1.25) | -0.6 |
| Deming | 100 | 0.9993 | 1.01 (1.00, 1.02) | -2.48 (-3.63, -1.33) | |
| Passing-Bablok | 100 | 0.9993 | 1.02 (1.01, 1.03) | 3.08 (-4.72, -1.97) | |

b. Software/Hardware Verification and Validation:

Various functional test protocols were used to validate the barcode read and transmission capabilities for the FlexLab 3.6/Architect c8000 system. The test protocols were found to be acceptable.

K. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

L. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.