THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS

K962864 · Alko Diagnostic Corp. · KRZ · Dec 18, 1996 · Hematology

Device Facts

• Record ID: K962864
• Device Name: THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS
• Applicant: Alko Diagnostic Corp.
• Product Code: KRZ · Hematology
• Decision Date: Dec 18, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8165
• Device Class: Class 2

Intended Use

The tHb Cal Standard is intended for use in calibrating the total hemoglobin channel of the IL CO-Oximeters and Oximeters.

Device Story

The tHb Cal Standard is an in vitro diagnostic solution used to calibrate the total hemoglobin (tHb) channel of Instrumentation Laboratory (IL) CO-Oximeters and Oximeters. It serves as a direct replacement for the OEM Cal Dye Reference Standard. The device is used in clinical laboratory settings by technicians or laboratory personnel to ensure the accuracy of blood gas and oximetry analyzers. By calibrating the tHb channel, the device ensures that subsequent patient blood sample measurements—such as O2Hb, COHb, MetHb, and O2 content—are accurate. This calibration process is essential for healthcare providers to make reliable clinical decisions regarding patient oxygenation status and hemoglobin levels.

Clinical Evidence

Bench testing only. Precision studies (N=15 per level) across three hemoglobin levels showed CV% ranging from 0.699% to 1.076%. Comparative analysis against the predicate on IL 282 and 482 analyzers demonstrated equivalent mean tHb values and performance within assayed control ranges. No clinical patient data provided.

Technological Characteristics

In vitro diagnostic calibration solution. Composition is similar to OEM Cal Dye Reference Standard. Designed for use with IL 282 and 482 CO-Oximeters/Oximeters. No electronic, software, or energy-based components; purely chemical calibration standard.

Indications for Use

Indicated for use as a calibration standard for the total hemoglobin channel in Instrumentation Laboratory CO-Oximeters and Oximeters. No specific patient population is described as this is an in vitro diagnostic calibration solution.

Regulatory Classification

Identification

A calibrator for hemoglobin or hematocrit measurement is a device that approximates whole blood, red blood cells, or a hemoglobin derivative and that is used to set instruments intended to measure hemoglobin, the hematocrit, or both. It is a material whose characteristics have been precisely and accurately determined.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Predicate Devices

• Instrumentation Laboratory Cal Dye™ Reference Standard

Reference Devices

• IL 282 Analyzer
• IL 482 Analyzer

Submission Summary (Full Text)

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ALKO

ALKO Diagnostic Corporation

A Life Sciences International Company

DEC 18 1996

K962864

# 510(k) Summary

## tHb Cal Standard

for Instrumentation Laboratory CO-Oximeters and Oximeters.

The product encompassed by this 510(k) submission is a Class II (81KRZ) In Vitro Diagnostic Solution manufactured by ALKO Diagnostic Corporation, 333 Fiske Street, Holliston, MA 01746. The tHb Cal Standard is intended for use in calibrating the total hemoglobin channel of the IL CO-Oximeters and Oximeters. Instrumentation Laboratory Company is the original equipment manufacturer (OEM) of the analyzer and of predicate Cal Dye™ Reference Standard which is necessary for calibrating the total hemoglobin channel on the IL CO-Oximeters and/Oximeters.

The tHb Cal Standard is intended to serve as direct replacement to like named product manufactured by Instrumentation Laboratory Company. ALKO Product A331-50 (tHb Cal Standard) is equivalent to Instrumentation Laboratory product 33150-50 (Cal Dye™ Reference Standard).

ALKO uses a similar composition, description and packaging design as that used by Instrumentation Laboratory Company in its products. ALKO has shown performance equivalence of its product to Instrumentation Laboratory Company’s product in the following manner:

- Through functional tests where results were obtained on Instrumentation Laboratory CO-Oximeters/Oximeters with ALKO product and were compared with results obtained on the same analyzer calibrated with Instrumentation Laboratory product.
- Through a precision study where ALKO product was used on an Instrumentation Laboratory Analyzer and samples were measured over 5 runs.
- Through a comparative analysis where tHb Cal Standard and IL Cal Dye™ Reference Standard were measured and compared with the assayed tHb values.

A summary of the results of these studies follows:

A Worldwide Supplier of Blood Gas and ISE

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ALKO Park • 333 Fiske Street • Holliston, MA 01746-2048 • USA • Phone: [phone] • [phone] • Fax: [phone]

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Page 2/ ALKO 510 (k) Summary for IL Cal Dye™ Reference Standard

# PERFORMANCE CHARACTERISTICS

## 1. Precision Data

Precision data were collected from the analysis of three levels of IL CO-OX controls (Human Hemoglobin based), 3 times per run, one run per day for 5 days, on a 482 analyzer calibrated with ALKO tHb Cal Standard. A separate calibration was performed prior to each run.

### tHb

| Level | | N | Mean | STD | CV% | Min | Max |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 1 | Total | 15 | 16.9 | 0.1181 | 0.6993 | 16.8 | 17.2 |
| | Run to Run | 5 | 16.9 | 0.0646 | 0.3826 | 16.8 | 17.0 |
| 2 | Total | 15 | 13.8 | 0.1147 | 0.8340 | 13.6 | 13.9 |
| | Run to Run | 5 | 13.8 | 0.0806 | 0.5857 | 13.6 | 13.9 |
| 3 | Total | 15 | 7.2 | 0.0772 | 1.0758 | 7.1 | 7.4 |
| | Run to Run | 5 | 7.2 | 0.0533 | 0.7435 | 7.1 | 7.3 |

## 2. Comparative Data

Comparative data were collected from the analysis of ALKO and IL tHb Cal Standards measured on IL 282 and 482 Analyzers.

### tHb

| Instrument | Product P/N, Lot No | N | Mean | STD | CV% | tHb min.- max. | Assay Value |
| --- | --- | --- | --- | --- | --- | --- | --- |
| on IL 282 | IL 33150, lot N0931981 | 15 | 14.7 | 0.0653 | 0.4450 | 14.6 - 14.8 | 14.8 |
| | ALKO A331-50, lot 10624 | 15 | 15.0 | 0.0499 | 0.3316 | 15.0 - 15.1 | 15.0 |
| on IL 482 | IL 33150, lot N1257163 | 15 | 14.9 | 0.0730 | 0.4901 | 14.8 - 15.0 | 14.9 |
| | ALKO A331-50, lot 50128 | 15 | 14.8 | 0.0442 | 0.2993 | 14.7 - 14.8 | 14.8 |

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ALKO Diagnostic Corporation • 333 Fiske Street • Holliston, MA 01746-2048 • USA • Phone: [phone] • Fax: [phone]

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Page 3/ ALKO 510(k) Summary for IL Cal Dye™ Reference Standard

## 3. Functional Tests

Functional tests of ALKO tHb Cal Standard were performed on IL 282 and 482 Analyzers and compared to IL Cal Dye™ Reference Standard. Both analyzers were calibrated with ALKO and IL tHb Standards separately. Three levels of IL CO-OX controls (Human Hemoglobin based) were measured in triplicate. The mean values are shown below.

### a) IL 282 Analyzer

| | | tHb(g/dL) | %O2Hb | %COHb | %MetHb | O2 Ct (Vol%) |
| --- | --- | --- | --- | --- | --- | --- |
| Calibrated with IL Cal Dye™ Reference Standard | Level 1 | 17.2 | 39.3 | 60.4 | 0.2 | 9.4 |
| | Level 2 | 12.8 | 96.3 | 3.7 | 0.5 | 17.2 |
| | Level 3 | 6.4 | 76.0 | 24.1 | 0.2 | 6.7 |
| Calibrated with ALKO tHb Cal Standard | Level 1 | 17.4 | 39.4 | 60.4 | 0.3 | 9.5 |
| | Level 2 | 13.0 | 96.1 | 4.0 | 0.5 | 17.4 |
| | Level 3 | 6.5 | 75.8 | 24.3 | 0.4 | 6.8 |
| Assayed Control Values | Level 1 | 16.6-17.6 | 37.1-41.1 | 58.6-62.0 | -0.9-3.1 | 8.5-10.5 |
| | Level 2 | 12.3-13.3 | 93.5-98.5 | 1.9-5.3 | -1.1-2.9 | 16.3-18.7 |
| | Level 3 | 6.0-7.0 | 73.7-77.7 | 22.1-25.5 | -1.0-3.0 | 6.2-7.4 |

### b) IL 482 analyzer

| | | tHb(g/dL) | %O2Hb | %COHb | %MetHb | O2 Ct (Vol%) | % RHb |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Calibrated with IL Cal Dye™ Reference Standard | Level 1 | 16.8 | 39.0 | 60.5 | 0.1 | 9.1 | 0.4 |
| | Level 2 | 13.7 | 97.3 | 2.2 | 0.2 | 18.5 | 0.3 |
| | Level 3 | 7.1 | 77.3 | 22.4 | 0.2 | 7.6 | 0.1 |
| Calibrated with ALKO tHb Cal Standard | Level 1 | 16.9 | 39.1 | 60.1 | 0.4 | 9.2 | 0.4 |
| | Level 2 | 13.8 | 97.1 | 2.1 | 0.3 | 18.6 | 0.4 |
| | Level 3 | 7.1 | 77.2 | 22.4 | 0.2 | 7.6 | 0.3 |
| Assayed ontrol Values | Level 1 | 16.6 to 17.6 | 35.6 to 39.6 | 59.6 to 63.0 | -0.8 to 3.2 | 8.1 to 10.1 | -1.3 to 1.1 |
| | Level 2 | 13.3 to 14.3 | 93.4 to 98.4 | 1.5 to 4.9 | -0.9 to 3.1 | 17.4 to 19.8 | -1.5 to 0.9 |
| | Level 3 | 6.7 to 7.7 | 74.1 to 78.1 | 21.0 to 24.4 | -0.6 to 3.4 | 7.1 to 8.3 | -1.5 to 0.9 |

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ALKO Diagnostic Corporation • 333 Fiske Street • Holliston, MA 01746-2048 • USA • Phone: [phone] • Fax: [phone]

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Page 4/ ALKO 510(k) Summary for Cal-Dye™ Reference Standard

## Conclusion

ALKO manufactures products that serve as functional equivalents to consumable distributed by Original Equipment Manufacturer. All such products are manufactured with the intent of complying with the Good Manufacturing Practice Regulations.

As previously stated the product encompassed by this request serves as a functional equivalent to the product currently manufactured and marketed by Instrumentation Laboratory of Lexington, MA USA. We believe that Instrumentation Laboratory has received 510 (k) market approval given that they are currently distributing the IL CO-Oximeter/Oximeter instruments and related consumable domestically. The previously described labeling and performance verification should provide adequate documentation as to the equivalence of the ALKO Product.

I hope you find the documentation provided informative and helpful.


Janet A. McGrath
Regulatory Affairs

A Worldwide Supplier of Blood Gas and ISE

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ALKO Diagnostic Corporation • 333 Fiske Street • Holliston, MA 01746-2048 • USA • Phone: [phone] • Fax: [phone]