CALIBRATING MATERIAL,CAL-PAK, CAL & SLOPE STANDARDS

K020596 · Diamond Diagnostics, Inc. · JIT · Mar 23, 2002 · Clinical Chemistry

Device Facts

• Record ID: K020596
• Device Name: CALIBRATING MATERIAL,CAL-PAK, CAL & SLOPE STANDARDS
• Applicant: Diamond Diagnostics, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Mar 23, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The reagents are intended for use on equivalent Corning Electrolyte Instruments to calibrate the electrodes and flush the sample flow path. Corning is the original equipment manufacturer (OEM) of the instruments and the predicate reagents which are necessary for the continued operation and use of the instruments. The Mission reagents are intended to serve as direct replacements to like named products manufactured by Corning. The OEM products were originally released under the Corning name.

Device Story

Mission Diagnostic Calibrating Reagents are aqueous salt-based solutions designed as direct replacements for Corning OEM reagents. Used in clinical laboratory settings on Corning 6X4 series electrolyte analyzers; reagents calibrate ion-selective electrodes (ISE) and flush sample flow paths. Operation involves loading reagents into the analyzer; the instrument uses these to establish calibration curves for analytes (Na+, K+, Cl-, Ca++, Li+). Healthcare providers use the resulting analyzer output to measure electrolyte concentrations in human serum samples. The device ensures continued instrument functionality and measurement accuracy, supporting clinical decision-making regarding patient electrolyte balance.

Clinical Evidence

Bench testing only. Precision data collected over minimum 7 days using three levels of QC material on Corning 614, 644, and 654 analyzers; %CVs ranged from 0.40% to 8.89%. Correlation studies performed on human serum samples (spiked with LiCl and analytes) comparing Mission-calibrated analyzers to Corning-calibrated analyzers. Linear regression analysis (Y=mX+b) showed slopes between 0.96 and 1.07 and R2 values ≥ 0.99 for Na, K, Cl, and Li, demonstrating performance equivalence.

Technological Characteristics

Aqueous reagents containing salts for analyte calibration and system rinsing. Designed for use with Corning 6X4 series electrolyte analyzers. No specific materials of construction or software algorithms described; device functions as a chemical calibrator for ISE-based diagnostic systems.

Indications for Use

Indicated for in-vitro diagnostic use on Corning 6X4 series electrolyte analyzers to calibrate electrodes and flush sample flow paths. Intended for use by laboratory professionals.

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

• 478541 614 Cal-Pak Na+/K+
• 478548 634 Cal-Pak Ca++/pH
• 473510 644 Cal-Pak Na+/K+/Cl-
• 473605 654 Cal-Pak Na+/K+/Li+

Submission Summary (Full Text)

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# 510(k) Summary for Mission Diagnostic Reagents on Corning 6X4 Electrolyte Analyzers

K020596

- 1. Submitter's Name & Address Mission Diagnostics 331 Fiske St Holliston MA 01746 FAX: [phone]
MAR 2 6 2002

508-429-0450

In Process Establishment Registration Number:

Date of Preparation:

February, 19, 2002

Contact Person:

Linda Stundtner

QA/RA Manager

# 2. Identification of the Device:

| Proprietary/Trade name: | Calibrating Material, Cal-Pak, Cal & Slope Standards |
|-------------------------|-----------------------------------------------------------|
| Common or usual name | Calibrators for ISE and/or pH/Blood Gas automated systems |
| Classification name: | Calibrator, secondary |
| Device Classification | II |
| Regulation Number: | 21 CFR § 862.1150 |
| Panel: | Chemistry (75) |
| Product Code: | JIT |

## 1.

#### Predicate Device: 2.

Mission claims substantial equivalence to the Corning Calibrators listed below:

| Mission Product | Corning Equivalent |
|-------------------------------------|-------------------------------|
| CD-478541AD Cal-Pak for Corning 614 | 478541 614 Cal-Pak Na+/K+ |
| CD-478548AD Cal Pak for Corning 634 | 478548 634 Cal-Pak Ca++/pH |
| CD-473510AD Cal-Pak for Corning 644 | 473510 644 Cal-Pak Na+/K+/Cl- |
| CD-473605AD Cal-Pak for Corning 654 | 473605 654 Cal-Pak Na+/K+/Li+ |

#### Device Description: 3.

The Calibrators for the Corning Electrolyte Instruments are aqueous reagents with salts added to obtain desired analyte levels to provide calibration of the electrodes and rinse the sample path.

#### 4. Intended Use:

- The reagents are intended for use on equivalent Corning Electrolyte Instruments to calibrate the . electrodes and flush the sample flow path.
- Corning is the original equipment manufacturer (OEM) of the instruments and the predicate . reagents which are necessary for the continued operation and use of the instruments.
- The Mission reagents are intended to serve as direct replacements to like named products . manufactured by Corning.
- The OEM products were originally released under the Corning name. .

510(k) Submission for Mission Diagnostics Reagents on Corning 6X4 Electrolyte Analyzers

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- Corning has under gone several owner and name changes: . Corning Glass, Ciba-Corning, Chiron, and currently Bayer.
- For the purposes of this 510(k) the OEM will be referred to as Corning. .
- Mission uses a similar composition, description and packaging as that used by Corning in its . products, as shown in the packaging section of this submission.
- Performance equivalence was shown in the following manner: .
- Precision data was collected from QC samples (or control material) measured over a o minimum of 7 days on an equivalent Corning analyzer where Mission products were installed.
- Correlation of serum sample results obtained on an equivalent Corning analyzer, o calibrated with Mission reagents and on the same analyzer calibrated with Corning reagents

A summary of the results of these studies follows:

# Performance Characteristics:

### Precision Data

Precision data were collected from the analysis of three levels of control materials, measured three r roolsion actu word over a minimum of 7 days on each Corning analyzer calibrated with all Mission reagents.

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#### Corning 614 Electrolyte Instrument Precison Data Table 1

Three levels of QC Material, Na, K precision values with Mission reagents.

| Corning | 614 | Na | | | | |
|---------|---------|------|--------|-----|-----|-------|
| | Mission | | | | | |
| Level | N | Mean | StdDev | Min | Max | %CV |
| QC1 | 24 | 112 | 0.9 | 110 | 113 | 0.79% |
| QC2 | 24 | 136 | 0.7 | 134 | 137 | 0.50% |
| QC3 | 24 | 159 | 0.8 | 158 | 161 | 0.50% |

Na

614 Corning

| | Mission | | | | | |
|-------|---------|------|--------|------|------|-------|
| Level | N | Mean | StdDev | Min | Max | %CV |
| QC1 | 24 | 1.93 | 0.032 | 1.85 | 1.99 | 1.67% |
| QC2 | 24 | 4.17 | 0.019 | 4.13 | 4.20 | 0.46% |
| QC3 | 24 | 6.58 | 0.060 | 6.49 | 6.72 | 0.92% |

K

#### Corning 644 Electrolyte Instrument Precison Data Table 2

Three levels of QC Material, Na, K, CI precision values with Mission reagents.

Corning 644 Na

| Mission | | | | | | |
|---------|----|------|--------|-----|-----|-------|
| Level | N | Mean | StdDev | Min | Max | %CV |
| QC1 | 24 | 108 | 0.6 | 107 | 109 | 0.56% |
| QC2 | 24 | 133 | 1.1 | 132 | 138 | 0.85% |
| QC3 | 23 | 157 | 1.1 | 155 | 159 | 0.72% |

644 Corning

K

| | Mission | | | | | |
|-------|---------|------|--------|------|------|-------|
| Level | N | Mean | StdDev | Min | Max | %CV |
| QC1 | 24 | 1.93 | 0.022 | 1.89 | 1.98 | 1.13% |
| QC2 | 24 | 4.10 | 0.016 | 4.08 | 4.14 | 0.40% |
| QC3 | 23 | 6.51 | 0.044 | 6.45 | 6.60 | 0.68% |

Corning 644 Cl

| | Mission | | | | | |
|-------|---------|------|--------|-----|-----|-------|
| Level | N | Mean | StdDev | Min | Max | %CV |
| QC1 | 24 | 81 | 1.1 | 79 | 84 | 1.40% |
| QC2 | 24 | 97 | 1.9 | 95 | 103 | 1.99% |
| QC3 | 23 | 128 | 2.4 | 125 | 135 | 1.85% |

510(k) Submission for Mission Diagnostics Reagents on Corning 6X4 Electrolyte Analyzers

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1

#### Corning 654 Electrolyte Instrument Precison Data Table 3

Three levels of QC Material, Na, K, Li precision values with Mission reagents.

| Corning | 654 |
|---------|-----|

Na

| | Mission | | | | | |
|-------|---------|------|--------|-----|-----|-------|
| Level | N | Mean | StdDev | Min | Max | %CV |
| QC1 | 21 | 109 | 1.9 | 104 | 113 | 1.75% |
| QC2 | 24 | 135 | 1.4 | 133 | 140 | 1.06% |
| QC3 | 24 | 159 | 2.1 | 154 | 163 | 1.32% |

654 Corning

K

| | Mission | | | | | |
|-------|---------|------|--------|------|------|-------|
| Level | N | Mean | StdDev | Min | Max | %CV |
| QC1 | 21 | 1.87 | 0.028 | 1.82 | 1.92 | 1.49% |
| QC2 | 24 | 4.10 | 0.027 | 4.04 | 4.16 | 0.65% |
| QC3 | 24 | 6.54 | 0.074 | 6.36 | 6.65 | 1.14% |

654 Corning

Li

| Mission | | | | | | |
|---------|----|------|--------|------|------|-------|
| Level | N | Mean | StdDev | Min | Max | %CV |
| QC1 | 21 | 0.29 | 0.026 | 0.24 | 0.35 | 8.89% |
| QC2 | 24 | 0.99 | 0.032 | 0.90 | 1.03 | 3.27% |
| QC3 | 24 | 2.24 | 0.084 | 2.05 | 2.36 | 3.75% |

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# Correlation with Corning Reagents

Correlation data were obtained from human serum samples for Na, K, Cl, Ca, and Li.

- Serum was first spiked with LiCI to obtain a base Li concentration. .
- Samples were then spiked to yield varying concentrations of each of the measuring o analytes.
- . Not all runs were specific for all analytes.
- Serum samples were measured each test day on Corning analyzers calibrated with . Mission reagents for 1 run then measured in a comparative run on Corning analyzers calibrated with Corning reagents.

Linear regression analysis was performed using Mission data as the independent X variable and Corning as the dependent Y variable in the equation Y = mX +b

| Na | | | | | |
|-----|----|-------|-----------|------|-----------|
| | N | Slope | Intercept | R2 | Range |
| 614 | 50 | 1.00 | 1.72 | 1.00 | 105 - 187 |
| 644 | 50 | 1.03 | 0.25 | 1.00 | 100 - 190 |
| 654 | 50 | 0.97 | 4.41 | 1.00 | 102 - 189 |

## Correlation Data Table 1

| K | | | | | |
|-----|----|-------|-----------|------|-------------|
| N | N | Slope | Intercept | R2 | Range |
| 614 | 60 | 1.01 | -0.01 | 1.00 | 2.53 - 6.31 |
| 644 | 60 | 1.04 | -0.11 | 1.00 | 2.47 - 6.24 |
| 654 | 60 | 1.07 | -0.20 | 1.00 | 2.43 - 6.45 |

| N | | Slope | Intercept | R2 | Range | |
|-----|----|-------|-----------|------|-------|-------------|
| 644 | Cl | 50 | 0.97 | 6.20 | 1.00 | 81 - 187 |
| 654 | Li | 30 | 0.96 | 0.06 | 0.99 | 0.32 - 1.54 |

Correlations demonstrated slopes of 1.0 and R2 's of ≥ 0.99, which support a claim of . substantial equivalence.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# MAR 2 6 2002

Diamond Diagnostics Inc. c/o Ms. Linda Stundtner QA/RA Manager Mission Diagnostics 333 Fiske Street Holliston, MA 01746

k020596 Re:

Trade/Device Name: Mission Diagnostic Calibrating Reagents for Corning 6X4 Electrolyte Analyzers

Regulation Number: 21 CFR 862.1150

Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: February 19, 2002 Received: February 22 2002

Dear Ms. Stundtner:

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, listing 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Putman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k( Number

Device Name: Mission Diagnostic Calibrating Reagetns for Corning 6X4 Electrolyte Analyzers

Kozo596

## Indication For Use:

The products encompassed by this request are intended for in-vitro diagnostics use and for use in r rie products enompassou by the route flow path of the equivalent Corning 6X4 Series Canbrating the Clectrodos and nashing the new changes inch.: Corning Glass, Ciba-Corning, Chiron, and currently Bayer) is the Original Equipment Manufacturer (OEM) of the analyzers and the predicate reagents.

| Mission Product | Corning<br>Instrument Used<br>on | |
|-----------------|----------------------------------|-----|
| CD-478541AD | Cal-Pak for Corning 614 | 614 |
| CD-478548AD | Cal Pak for Corning 634 | 634 |
| CD-473510AD | Cal-Pak for Corning 644 | 644 |
| CD-473605AD | Cal-Pak for Corning 654 | 654 |

Mission reagents are intended to serve as direct replacements to like named products manufactured by Corning (under the label of current owner, Bayer).

The products encompassed are to be handled using normal laboratory precautions.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of the Device Evaluation (ODE)

prescription use ✓

Carol C. Benson for Jean Cooper

ision Sian-

(Optional format 3-10-98)

510(k) Submission for Mission Diagnostics Reagents on Corning 6X4 Electrolyte Analyzers