CALIBRATION PACK, MODELS A9100-101S AND A9100-103S

K023792 · Thermo Orion · JIX · Jan 31, 2003 · Clinical Chemistry

Device Facts

• Record ID: K023792
• Device Name: CALIBRATION PACK, MODELS A9100-101S AND A9100-103S
• Applicant: Thermo Orion
• Product Code: JIX · Clinical Chemistry
• Decision Date: Jan 31, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The products encompassed by this request are intended for in vitro diagnostic use only and are intended for use in the calibration of equivalent Roche/AVL 9100 Series Electrolyte Analyzers .

Device Story

Calibration Packs (A9100-101S, A9100-103S) serve as replacement calibration standards for Roche/AVL 9100 Series Electrolyte Analyzers. Packs contain standardized solutions (Standard A, B, C, Reference Solution) and waste containers. Used in clinical laboratory settings by trained personnel to calibrate Ion Selective Electrode (ISE) analyzers. Calibration ensures accuracy of quantitative electrolyte measurements (Na+, K+, Cl-, Ca++, Li+). Healthcare providers use analyzer output to assess patient electrolyte status; device facilitates diagnostic testing by maintaining analyzer performance.

Clinical Evidence

Bench testing only. Precision studies conducted over 23-24 days using human serum-based materials in duplicate. Total CV% ranged from 0.44% to 2.15% across analytes. Method comparison study (N=46-57 samples) against predicate showed high correlation (R squared 0.9988-0.9999) and slopes near 1.0 (0.9786-1.0073) for Na+, K+, Cl-, Ca++, and Li+.

Technological Characteristics

Multi-analyte calibration standards for ISE analyzers. Aqueous solutions containing electrolytes (Na+, K+, Cl-, Ca++, Li+). Designed for use with Roche/AVL 9100 series hardware. No electronic or software components; purely chemical calibration standards.

Indications for Use

Indicated for in vitro diagnostic use to calibrate Roche/AVL 9100 Series Electrolyte Analyzers for the quantitative determination of electrolytes (Na+, K+, Cl-, Ca++, Li+) in human serum samples.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

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 § 862.9.

Predicate Devices

• AVL ISE SnapPak™ (K961458)

Submission Summary (Full Text)

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# 510(k) Summary for Thermo ALKO Calibration Packs for use on Equivalent AVL 9100 Series Electrolyte Analyzers

#### 1. Submitter's Name and Address:

Thermo Orion, Inc. Thermo ALKO 500 Cummings Center Beverly, MA 01915

### Contact Person:

Patrick K. Chiu Quality Assurance Manager Thermo ALKO products [phone]

Date of Preparation: November 12, 2002

#### 2. Device Identification:

| Proprietary name/Trade name: | Calibration Pack |
|------------------------------|-------------------------------------------------------|
| Common or usual name: | Calibration Standards for Electrolyte (ISE) Analyzers |
| Classification name: | Calibrator, Multi-Analyte Mixture |
| Device Classification: | II |
| Regulation Number: | 21 CFR 862.1150 |
| Panel: | Clinical Chemistry (75) |
| Product Code: | JIX |

#### Substantial Equivalence: 3.

Thermo ALKO Calibration Packs, Product No. A9100-101S and A9100-103S, are claimed to be substantially equivalent to AVL ISE SnapPak™, Product Number BP5016 and BP5186, respectively, (encompassed in the 510(k) under the device name "AVL 9180 Electrolyte Analyzer", 510(k) number K961458 previously cleared by the FDA on 06/12/1996), manufactured and distributed by Roche Diagnostics (AVL Scientific).

#### Device Description: 4.

Thermo ALKO Calibration Packs are intended for use on equivalent Roche/AVL 9100 Series Analyzers. Calibration Pack, Product No. A9100-101S, contains Standard A, Standard B, Reference Solution and a waste container. It is intended for calibration of equivalent Roche/AVL 9120 and 9130 Analyzers, Calibration Pack, Product No. A9100-103S, contains Standard B, Standard C, Reference Solution and a waste container. It is intended for calibration of equivalent Roche/AVL 9180 and 9181 Analyzers.

A VL Scientific, a trade name owned by Roche Diagnostics, is the original equipment manufacturer (OEM) of the analyzers and of predicate device (ISE SnapPak™) which is necessary for the continued operation and use of the analyzers. The Roche/AVL 9100 Series Analyzers perform electrolyte tests wherein samples are analyzed for the quantitative determinations of electrolytes by Ion Selective Electrode (ISE) method. Both Roche/AVL 9120 and 9130 Analyzers can measure Na and K* with the exception that the Roche/AVL 9130 also measures CI in addition to Na ' and K '. Both Roche/AVL 9180 and 9181 Analyzers can measure Nat, K+, CJ , Ca+ , and Li+ with the exception that the Roche/AVL 9181 has an added autosampler.

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Thermo ALKO Calibration Packs are intended to be used with equivalent Roche/AVL Analyzers. As such, Thermo Orion (Thermo ALKO) products are intended to serve as direct replacements to like named products manufactured and distributed by Roche Diagnostics (AVL Scientific).

Thermo Orion (Thermo ALKO) uses a similar composition and packaging design as that used by Roche Diagnostics (AVL Scientific) in its products. Thermo Orion (Thermo ALKO) has shown performance equivalence of its products to the Roche Diagnostics (AVL Scientific) products in the following manner:

- O Through a method comparison where results are obtained on equivalent Roche/AVL Analyzers, calibrated with Thermo Orion (Thermo ALKO) products and are compared with results obtained on the same Analyzers calibrated with Roche Diagnostics (AVL Scientific) products; and
- Through a precision study where Thermo Orion (Thermo ALKO) products were installed on equivalent Roche/AVL Analyzers and samples were measured in multiple runs over a defined period.

A summary of the results of these studies follows:

#### న్. Performance Characteristics:

# Thermo ALKO Calibration Pack, Product Number A9100-101S:

## Precision Data

Precision data were collected from the analysis of two levels of human serum based materials in duplicate per run on an AVL 9130 analyzer over a period of 23 days calibrated with Thermo ALKO Calibration Pack.

| Level | Analyte | Ttl Runs | Mean | Ttl SD | Ttl CV% | WR SD | WR CV% |
|---------|---------|----------|-------|--------|---------|-------|--------|
| Level 1 | Na+ | 25 | 116.4 | 0.63 | 0.54 | 0.34 | 0.29 |
| | K+ | 25 | 2.71 | 0.055 | 2.03 | 0.017 | 0.62 |
| | Cl- | 25 | 103.6 | 1.24 | 1.20 | 0.32 | 0.31 |
| Level 2 | Na+ | 25 | 149.8 | 1.09 | 0.73 | 0.36 | 0.24 |
| | K+ | 25 | 6.09 | 0.072 | 1.18 | 0.029 | 0.47 |
| | Cl- | 25 | 139.9 | 2.39 | 1.71 | 0.32 | 0.23 |

WR SD = within-run standard deviation Ttl SD = total standard deviation

# Correlation Data

Correlation data were obtained from 47 human serum samples and control materials for Na . K and Cli measured on an AVL 9130 Analyzer, calibrated with Thermo ALKO Calibration Pack and AVL ISE SnapPak™, separately. Linear Regression Analysis was performed using Thermo ALKO Data as the Dependent Y Variable and AVL Data as the Independent X Variable in the equation Y = a + bX. Values of R Squared are 0.9993 for Nat, 0.9988 for K+ and 0.9989 for Cli. Values of slopes are 0.9796 for Nat, 0.9786 for K+ and 0.9818 for Cl .

| Analyte | (N) | Slope | Intercept | R Sq | Range (mM) |
|---------|-----|--------|-----------|--------|---------------|
| Na+ | 56 | 0.9796 | 2.2385 | 0.9993 | 65.1 to 187.6 |
| K+ | 56 | 0.9786 | 0.0633 | 0.9988 | 1.80 to 11.5 |
| Cl- | 52 | 0.9818 | 2.0605 | 0.9989 | 50.1 to 163.5 |

R Sq = Correlation coefficient Squared

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## Thermo ALKO Calibration Pack, Product Number A9100-103S:

### Precision Data

Precision data were collected from the analysis of two levels of human serum based materials in duplicate per run on an AVL 9180 analyzer over a period of 24 days calibrated with Thermo ALKO Calibration Pack.

| Level | Analyte | Ttl Runs | Mean | Ttl SD | Ttl CV% | WR SD | WR CV% |
|---------|---------|----------|-------|--------|---------|-------|--------|
| Level 1 | Na+ | 22 | 115.8 | 0.51 | 0.44 | 0.41 | 0.35 |
| | K+ | 22 | 2.71 | 0.029 | 1.08 | 0.017 | 0.62 |
| | Cl- | 22 | 101.5 | 0.91 | 0.90 | 0.27 | 0.27 |
| | Ca++ | 22 | 0.90 | 0.019 | 2.07 | 0.016 | 1.80 |
| | Li+ | 22 | 1.025 | 0.022 | 2.11 | 0.013 | 1.31 |
| Level 2 | Na+ | 22 | 149.5 | 0.91 | 0.61 | 0.36 | 0.24 |
| | K+ | 22 | 6.21 | 0.047 | 0.76 | 0.036 | 0.57 |
| | Cl- | 22 | 141.2 | 0.88 | 0.62 | 0.40 | 0.29 |
| | Ca++ | 22 | 1.71 | 0.037 | 2.15 | 0.031 | 1.80 |
| | Li+ | 22 | 2.906 | 0.046 | 1.58 | 0.011 | 0.39 |

WR SD = within-run standard deviation

Ttl SD = total standard deviation

### Correlation Data:

Correlation data were obtained from 48 human serum samples and control materials for Na , K , Cl , Cat and Li+ measured on an AVL 9180 Analyzer, calibrated with Thermo ALKO Calibration Pack and AVL ISE SnapPak™, separately. Linear Regression Analysis was performed using Thermo ALKO Data as the Dependent Y Variable and AVL Data as the Independent X Variable in the equation Y = a + bX. Values of R Squared are 0.9998 for Na *, 0.9993 for K*, 0.9999 for Cl', 0.9994 for Ca" and 0.9994 for Lit. Values of slopes are 0.9991 for Nat, 1.0069 for K , 1.0032 for Cl~, 1.0073 for Ca** and 0.9930 for Li*.

| Analyte | (N) | Slope | Intercept | R Sq | Range (mM) |
|---------|-----|--------|-----------|--------|---------------|
| Na+ | 57 | 0.9991 | -0.3118 | 0.9998 | 65.0 to 198.4 |
| K+ | 57 | 1.0069 | -0.0513 | 0.9993 | 1.75 to 12.03 |
| Cl- | 50 | 1.0032 | -0.4125 | 0.9999 | 55.3 to 174.9 |
| Ca++ | 55 | 1.0073 | -0.0166 | 0.9994 | 0.24 to 4.91 |
| Li+ | 46 | 0.9930 | -0.0089 | 0.9994 | 0.21 to 5.63 |

R Sq = Correlation Coefficient Squared

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines suggesting hair or fabric. The profiles are arranged in a stacked formation, creating a sense of depth and unity. Encircling the image is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# JAN 3 1 2003

Mr. Patrick K. Chiu Quality Assurance Manager Thermo Orion, Inc. 500 Cummings Center Beverly, MA 01915

k023792 Re:

> Trade/Device Name: Calibration Packs for use on equivalent Roche/AVL 9100 Electrolyte Analyzers Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: November 12, 2002 Received: November 13, 2002

Dear Mr. Chiu:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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### 510(k) Number: K023792

Calibration Packs for use on equivalent Roche/AVL 9100 Series Electrolyte Device Name: Analyzers

#### Indications For Use:

The products encompassed by this request are intended for in vitro diagnostic use only and are intended for use in the calibration of equivalent Roche/AVL 9100 Series Electrolyte Analyzers .

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