INTEGRATED LABORATORY AUTOMATION SOLUTION

K091975 · Integrated Laboratory Automation Solutions, Inc. · CGA · Mar 10, 2010 · Clinical Chemistry

Device Facts

• Record ID: K091975
• Device Name: INTEGRATED LABORATORY AUTOMATION SOLUTION
• Applicant: Integrated Laboratory Automation Solutions, Inc.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Mar 10, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Integrated Laboratory Automation Solution (ILAS) is designed to transport clinical patient samples to clinical laboratory analyzers that perform the actual clinical tests. The ILAS system receives downloads from the Laboratory Information System (LIS) with the patient ID and test orders to be performed by the laboratory analyzer. The patient specimens are loaded onto the ILAS and bar codes are read. The bar codes are read at each analyzer station to determine if tests are to be run and if so the specimen is switched to a side track supplying the analyzer with the specimen. The ILAS is an accessory to the Vitros 250 automated chemistry analyzer and other similar chemistry automated clinical analyzers. Automated clinical analyzers utilize various methods and technologies for the determination of numerous analytes, such as Glucose and other measurands that may be adaptable to each integrated analyzer. Glucose on the ILAS system is for the quantitative in vitro diagnostic measurement of Glucose in plasma. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Device Story

ILAS is an automated conveyor system for clinical laboratories; transports blood/urine specimens to analyzers. Input: LIS downloads (patient ID, test orders) and barcode scans from specimen tubes. Operation: System reads barcodes at analyzer stations; switches specimens to side tracks for specific analyzers based on LIS test orders. Output: Physical routing of specimens to analyzers. Used in clinical labs; operated by lab personnel. ILAS does not perform testing or report results; results transmitted directly from analyzer to LIS. Benefit: Automates sample handling, reduces manual entry, and improves sample identification reliability compared to manual methods.

Clinical Evidence

Bench testing only. Performance evaluated by comparing analyte results from third-party analyzers with and without the ILAS interface. Results demonstrated significant correlation (r > 0.999) and percent differences within established analyte interassay variability.

Technological Characteristics

Laboratory automation software and hardware accessory. Interfaces with clinical analyzers (fluorometers, photometric chemistry, coagulation timers, cell counters). Provides automated information transfer to analyzers. Does not alter analyzer principles of operation or technological characteristics.

Indications for Use

Indicated for transport of clinical patient blood and urine samples to laboratory analyzers for diagnostic testing, including quantitative measurement of glucose in plasma for diagnosis/treatment of carbohydrate metabolism disorders (diabetes, hypoglycemia, pancreatic islet cell carcinoma).

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Vitros 250 automated chemistry analyzer (K922072)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE

A. 510(k) Number:
k091975

B. Purpose for Submission:
The submission is for obtaining clearance for The Integrated Laboratory Automation (ILAS) Solution an accessory to clinical laboratory analyzers such as Vitros 250 automated chemistry analyzer. The submission uses the Vitros 250 automated chemistry analyzer to demonstrate ILAS barcode sample ID transmission to analyzer and analytical equivalence to manual sample introduction verses automated sample introduction on the analyzer. The Vitros 250 automated chemistry analyzer was cleared with glucose under K922072.

C. Measurand:
Glucose

D. Type of Test:
Enzymatic

E. Applicant:
Integrated Laboratory Automation Solutions, Inc.

F. Proprietary and Established Names:
Integrated Laboratory Automation Solution (ILAS)

G. Regulatory Information:

1. Regulation section:
| Regulation | Name | Class |
| --- | --- | --- |
| 21CFR Sec.- 862.1345: | Glucose test system. | 2 |
| 21CFR Sec.- 862.2160: | Discrete photometric chemistry analyzer for clinical use. | 1 |

2. Product code:
| Product code | Device Name |
| --- | --- |
| CGA | GLUCOSE OXIDASE, GLUCOSE |
| JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |

3. Panel:
CH (75)

H. Intended Use:

1. Intended use(s):

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See Indications(s) for use below

2. Indication(s) for use:

The Integrated Laboratory Automation Solution (ILAS) is designed to transport clinical patient samples to clinical laboratory analyzers that perform the actual clinical tests. The ILAS system receives downloads from the Laboratory Information System (LIS) with the patient ID and test orders to be performed by the laboratory analyzer. The patient specimens are loaded onto the ILAS and bar codes are read. The bar codes are read at each analyzer station to determine if tests are to be run and if so the specimen is switched to a side track supplying the analyzer with the specimen.

The ILAS is an accessory to the Vitros 250 automated chemistry analyzer and other similar chemistry automated clinical analyzers. Automated clinical analyzers utilize various methods and technologies for the determination of numerous analytes, such as Glucose and other measurands that may be adaptable to each integrated analyzer.

Glucose on the ILAS system is for the quantitative in vitro diagnostic measurement of Glucose in plasma. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

3. Special conditions for use statement(s):

Prescription use

4. Special instrument requirements:

Vitros 250 automated chemistry analyzer.

I. Device Description:

The automation system (ILAS) is designed to transport clinical patient specimens (blood and urine) to the laboratory analyzers that perform the actual clinical tests. The ILAS system receives downloads from the Laboratory Information System (LIS) with the patient ID and menu of tests to be performed by the laboratory analyzers. The patients specimens are loaded onto the ILAS and bar codes are read. The bar codes are read at each laboratory analyzer station to determine whether the specimen should be directed to that specific analyzer. If a test is to be run on the analyzer, the specimen is switched to a side track supplying the testing analyzer with clinical specimens. All reporting of clinical specimen test results are transmitted from the analyzer to the LIS and the ILAS software is not involved in test results reporting.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Vitros 250 automated chemistry analyzer

2. Predicate 510(k) number(s):

K922072

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3. Comparison with predicate:

| Item | Integrated Laboratory Automation Solution (ILAS) | Analyzer Ex.: Ortho Clinical Diagnostics Vitros 250 AT Analyzers (K922072) | Lab-Interlink AWCC Software K010500 | Same or Different |
| --- | --- | --- | --- | --- |
| IFU | The Integrated Laboratory Automation Solution (ILAS) is designed to transport clinical patient samples to clinical laboratory analyzers that perform the actual clinical tests. The ILAS system receives downloads from the Laboratory Information System (LIS) with the patient ID and test orders to be performed by the laboratory analyzer. The patient specimens are loaded onto the ILAS and bar codes are read. The bar codes are read at each analyzer station to determine if tests are to be run and if so the specimen is switched to a side track supplying the analyzer with the specimen.The ILAS is an accessory to the Vitros 250 automated chemistry analyzer and other similar chemistry automated clinical analyzers. Automated clinical analyzers utilize various methods and technologies for the determination of numerous analytes, such as Glucose and other measurands that may be adaptable to each integrated analyzer.Glucose on the ILAS system is for the quantitative in vitro diagnostic measurement of Glucose in plasma. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. | The Ortho Clinical Diagnostics Vitros 250 AT Automated Analyzer is used for in vitro diagnostic use. | The AWCC software is an accessory to analyzer instruments, including for example, discrete photometric chemistry analyzers, coagulation timers, fluorometers, and/or cell counters. These analyzers are intended for use in conjunction with certain materials to measure a variety of analytes, to determine the onset of clot formation for I vitro coagulation studies, to identify and classify one or more of the formed elements of the blood, and/or other indications for which third arty analyzers are legally marketed. | Same |
| Software Driven | Yes | Yes | Yes | Same |

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| Item | Integrated Laboratory Automation Solution (ILAS) | Analyzer Ex.: Ortho Clinical Diagnostics Vitros 250 AT Analyzers (K922072) | Lab-Interlink AWCC Software K010500 | Same or Different |
| --- | --- | --- | --- | --- |
| Tube types | 16 x 100 mm, 13 x 100, and 13 x 75 mm | 16 x 100 mm, 13 x 100, and 13 x 75 mm | 16 x 100 mm, 13 x 100, and 13 x 75 mm | Same |
| Power requirements | Depends on number of modules on the conveyor system. Typically, for a conveyor 100 feet in length the power required is less than 10 amps at 115 VAC | | Greater power consumption, exact amount is information is no longer available. | Different Less power is required. This does not affect Safety and Efficacy in a negative manner. |
| Conveyor speed | Approximately 28-30 feet/minute | n/a | Approximately 20-25 feet/minute | Minor difference |
| Conveyor capacity | Approximately 2200 carriers/hour | n/a | Approximately 300-400/hour | Minor Difference |
| Sample Identification | Direct identification of sample by single bar code on sample.. | n/a | Indirect identification by bar code on tube and a different bar code on carrier, prone sample mix-ups. Bar code on tube must be mapped to bar code on carrier. Should the tube be removed by tech there is a good chance of sample misidentification. | Different: Direct ID is much more reliable. This difference does not impact Safety and Effectiveness in a negative manner. |
| Entering samples on conveyor | Sample tube is simply placed in carrier at loading station. No manual entry required. Automated bar code read and download of pending tests from LIS | n/a | Must remove sample tray from robot, scan bar code on tray, manually enter tube size, must place in assigned tray location, place tray back in robot. Presents bottleneck at sample loading area. | Different: This does not affect Safety and efficacy since the bar code is automatically read for the tests. No manual entry is required. |

K. Standard/Guidance Document Referenced (if applicable):
None Referenced

L. Test Principle:
Enzymatic

M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Provided in k922072
b. Linearity/assay reportable range:
Provided in k922072

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c. Traceability, Stability, Expected values (controls, calibrators, or methods): Provided in k922072
d. Detection limit: Provided in k922072
e. Analytical specificity: Provided in k922072
f. Assay cut-off: Provided in k922072

# 2. Comparison studies:

a. Method comparison with predicate device: The method correlation comparison study was conducted between a stand-alone Vitros 250 analyzer and a Vitros 250 analyzer integrated with the ILAS system yielded the following results for the Glucose.

| | Number of Specimens | Correlation Coefficient | Slope | Y-axis Intercept |
| --- | --- | --- | --- | --- |
| Glucose | 50 | 0.9999 | 1.005 | 0.1 |

b. Matrix comparison: Provided in k922072

3. Clinical studies:

a. Clinical Sensitivity: Not Applicable
b. Clinical specificity: Not Applicable
c. Other clinical supportive data (when a. and b. are not applicable): Not Applicable

4. Clinical cut-off: Not Applicable
5. Expected values/Reference range: Provided in k922072

# N. Instrument Name:

INTEGRATED LABORATORY AUTOMATION SOLUTION

# O. System Descriptions:

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1. **Modes of Operation:**
The ILAS system receives downloads from the Laboratory Information System (LIS) with the patient ID and menu of tests to be performed by the laboratory analyzers. The patients specimens are loaded onto the ILAS and bar codes are read and transported on the track. If a test is to be run on the analyzer, the specimen is switched to a side track supplying the testing analyzer with clinical specimens. All reporting of clinical specimen test results are transmitted from the analyzer to the LIS and the ILAS software is not involved in test results reporting.

2. **Software:**
FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types:
Yes ☐ X or No ☐
The applicant provided software documentation that supports the device was designed and developed under good software LifeCycle processes.

3. **Specimen Identification:**
Bar coded

4. **Specimen Sampling and Handling:**
The patients specimens are loaded onto the ILAS and bar codes are read. The bar codes are read at each laboratory analyzer station to determine whether the specimen should be directed to that specific analyzer.

5. **Calibration:**
Provided in k922072

6. **Quality Control:**
Provided in k922072

P. **Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above:**
Various functional test protocols were used to validate the barcode read and transmission capabilities for the Integrated Laboratory Automation Solution

Q. **Proposed Labeling:**
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

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