CALIBRATING MATERIAL, CALIBRATING STANDARDS

K031159 · Diamond Diagnostics, Inc. · JIT · Jun 25, 2003 · Clinical Chemistry

Device Facts

• Record ID: K031159
• Device Name: CALIBRATING MATERIAL, CALIBRATING STANDARDS
• Applicant: Diamond Diagnostics, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Jun 25, 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 diagnostics use and are intended for use in calibrating the electrodes. Mission reagents are intended to serve as direct replacements to like named products manufactured by the OEM. The products encompassed are to be handled using normal laboratory precautions.

Device Story

Mission Diagnostic Fluid Packs are self-contained, closed reagent packages containing calibrating and wash reagents for ISE (ion-selective electrode) automated electrolyte analyzers. The packs are designed as direct replacements for OEM-manufactured solutions (e.g., Medica EasyLyte, IL Test, Menarini Spotlyte). The reagents consist of aqueous solutions with specific salt concentrations to achieve desired analyte levels for calibration. The packs slide into the front of the instrument. During operation, the analyzer uses these reagents to calibrate the electrodes, ensuring accurate measurement of electrolytes (Na, K, Cl, Li, Ca, pH) in human serum samples. The output is a calibrated instrument state, allowing the healthcare provider to obtain accurate patient electrolyte results. These reagents are used in clinical laboratory settings by trained technicians. By maintaining instrument calibration, the device supports accurate clinical decision-making regarding patient electrolyte balance.

Clinical Evidence

Bench testing only. Precision data collected over 12 runs per analyte level showed %CVs comparable to the predicate. Correlation studies (N=55 for Na, K, Cl; N=15 for Li) using human serum samples spiked to varying concentrations demonstrated high correlation (R2 0.99-1.00) and slopes of 0.9-1.0 when compared to the predicate device.

Technological Characteristics

Aqueous reagent solutions containing salts for analyte calibration. Form factor is a self-contained, closed fluid pack designed for insertion into specific automated ISE analyzers. No specific materials of construction or sterilization methods are detailed beyond the chemical composition of the reagents.

Indications for Use

Indicated for in-vitro diagnostic use in calibrating electrodes on automated electrolyte analyzers. Intended for use by laboratory professionals as a direct replacement for OEM-manufactured calibrating reagents.

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

• EasyLyte Na,K,Cl, Li Analyzer (K963763)

Submission Summary (Full Text)

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# JUN 2 2 2003

16031159

# 510(k) Summary for Mission Diagnostic Fluid Packs on MEDICA Electrolyte Analyzers

| 1. Submitter's Name & Address | Mission Diagnostics<br>331 Fiske St<br>Holliston MA 01746<br>FAX: [phone] |
|------------------------------------|--------------------------------------------------------------------------------|
| Contact Person: | Linda Stundtner<br>QA/RA Manager<br>508-429-0450 |
| Establishment Registration Number: | 3003656721 |
| Date of Preparation: | April 11, 2003 |
| 2. Identification of the Device: | |
| Proprietary/Trade name: | Calibrating Material, Calibrating standards |
| Common or usual name | Calibrator Pack, Fluid Pack for ISE automated systems |
| Classification name: | Calibrator, secondary |
| Device Classification | II |
| Regulation Number: | 21 CFR § 862.1150 |
| Panel: | Chemistry (75) |

JIT

- Mission manufactures calibrators intended to serve as direct replacements to like named products manufactured by Original Equipment Manufactures (OEM)
#### 3. Predicate Device:

Product Code:

- Mission claims substantial equivalence to the predicate device, Electrode, ion-specific, sodium; . EasyLyte Na,K,Cl, Li Analyzer; K963763, MEDICA CORP.

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| Mission Product | | Predicate Device | |
|------------------------|-----------------------------------------------|------------------|-----------------------------------------------------------|
| ME-2120D &<br>ME-2109D | Medica 800 & 400 ml Fluid Packs<br>Na/K | 2120 &<br>2109 | Medica EasyLyte 800 & 400 ml Solutions Pack<br>Na/K |
| ME-2121D &<br>ME-2112D | Medica 800 & 400 ml Fluid Packs<br>Na/K/Cl | 2121 &<br>2112 | Medica EasyLyte 800 & 400 ml Solutions Pack<br>Na/K/Cl |
| ME-2122D &<br>ME-2115D | Medica 800 & 400 ml Fluid Packs<br>Na/K/Li | 2122 &<br>2115 | Medica EasyLyte 800 & 400 ml Solutions Pack<br>Na/K/Li |
| ME-2123D &<br>ME-2114D | Medica 800 & 400 ml Fluid Packs<br>Na/K/Ca/pH | 2123 &<br>2114 | Medica EasyLyte 800 & 400 ml Solutions Pack<br>Na/K/Ca/pH |
| ME-2026D &<br>ME-2028D | Medica 800 & 400 ml Fluid Packs<br>Na/K/Cl/Li | 2026 &<br>2028 | Medica EasyLyte 800 & 400 ml Solutions Pack<br>Na/K/Cl/Li |
| IL-2120D | ILyte 800 Fluid Pack Na/K | ME002120 | IL Test™ 800 Solutions Pack<br>Na/K |
| IL-2121D | ILyte 800 Fluid Pack Na/K/Cl | ME002121 | IL Test™ 800 Solutions Pack<br>Na/K/Cl |
| IL-2120D | ILyte 800 Fluid Pack Na/K/Li | ME002122 | IL Test™ 800 Solutions Pack<br>Na/K/Li |
| IL-2123D | ILyte Fluid Pak Na/K/Ca/pH | ME002123 | IL Test™ 800 Solutions Pack<br>Na/K/Ca/pH |
| IL-2026D | ILyte 800 Fluid Pack Na/K/Cl/Li | ME002026 | IL Test™ 800 Solutions Pack<br>Na/K/Cl/Li |
| MN-2120D | Menarini 800 Fluid Pack Na/K | Not Known | Spotlyte™ 800 Solutions Pack<br>Na/K |
| MN-2121D | Menarini 800 Fluid Pack Na/K/Cl | Not Known | Spotlyte™ 800 Solutions Pack<br>Na/K/Cl |
| MN-2120D | Menarini 800 Fluid Pack Na/K/Li | Not Known | Spotlyte™ 800 Solutions Pack<br>Na/K/Li |
| MN-2123D | Menarini Fluid Pak Na/K/Ca/pH | Not Known | Spotlyte™ 800 Solutions Pack Na/K/Ca/pH |
| MN-2026D | Menarini 800 Fluid Pack Na/K/Cl/Li | Not Known | Spotlyte™ 800 Solutions Pack Na/K/Cl/Li |

# Substantial Equivalence Table of Product PN's & Trade Names

- The Mission Fluid Packs (PN = ME-XXXXD or IL-XXXXD or MN-XXXXD) are . equivalent to the Medica EasyLyte Solutions Packs or IL Test™ Solutions Packs or Menarinin Spotlyte™ Packs. They are a self-contained closed reagent package containing all the calibrating and wash reagents. The Solutions Packs slide into the front of the instrument for operation.
#### 4. Device Description:

- . The Calibrators for the OEM Instruments are aqueous reagents with salts (chemical constituents) added to obtain desired analyte levels to provide the desired calibration.
#### . Intended Use:

- . The reagents are intended for use in place of predicate devices.
- The original equipment manufacturer (OEM) of the instruments and the predicate reagents . which are necessary for the continued operation and use of the instruments.
- Mission uses a similar composition, description and packaging as that used by the OEM in its . products, as shown in the packaging section of this submission.

# 5. Performance Characteristics:

Precision and correlation data are collected per:

- SOP23-01-02 Performance Study Protocol for 510(K) Submission t
- Data for each instrument and each run are recorded on SOP23-03F Performance Study t Record Sheet. (See Attachment Section for Copy of Procedures)

# 510(k) Submission for Mission Diagnostics Reagents on Electrolyte Analyzers

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## Precision Data

Precision data were collected from the analysis of three levels of control materials during a minimum of two runs per day on the Medica analyzers calibrated with all Mission reagents and when calibrated with Medica reagents.

Data shows that QC precision with Mission Fluid Packs was substantially equivalent to the QC precision with Medica Fluid Packs.

| Analyte | Level | N | Mean | sd | Min | Max | %CV |
|---------|-------|----|-------|------|-------|-------|-----|
| Na | 1 | 12 | 115.1 | 3.0 | 110.0 | 121.1 | 2.6 |
| | 2 | 12 | 135.6 | 1.2 | 133.0 | 138.0 | 0.9 |
| | 3 | 12 | 159.6 | 2.8 | 156.0 | 166.0 | 1.8 |
| K | 1 | 12 | 2.05 | 0.07 | 1.97 | 2.19 | 3.5 |
| | 2 | 12 | 4.21 | 0.02 | 4.17 | 4.24 | 0.5 |
| | 3 | 12 | 6.63 | 0.05 | 6.48 | 6.69 | 0.8 |
| Cl | 1 | 12 | 72.3 | 2.6 | 67.9 | 77.0 | 3.6 |
| | 2 | 12 | 91.4 | 3.3 | 82.0 | 96.0 | 3.6 |
| | 3 | 12 | 114.3 | 4.9 | 102.0 | 118.0 | 4.3 |
| Li | 1 | 12 | 0.32 | 0.09 | 0.22 | 0.49 | |
| | 2 | 12 | 1.10 | 0.01 | 1.09 | 1.12 | |
| | 3 | 12 | 2.25 | 0.14 | 1.98 | 2.38 | |

#### MEDICA Precision Data w/ MISSION REAGENTS

#### MEDICA Precision Data w/ MEDICA REAGENTS

| Analyte | Level | N | Mean | sd | Min | Max | %CV |
|---------|-------|----|-------|------|-------|-------|-----|
| Na | 1 | 12 | 116.4 | 5.4 | 106.0 | 128.0 | 4.6 |
| | 2 | 12 | 136.8 | 3.5 | 131.0 | 142.0 | 2.5 |
| | 3 | 12 | 159.9 | 2.9 | 155.0 | 165.0 | 1.8 |
| K | 1 | 12 | 2.06 | 0.06 | 1.96 | 2.19 | 2.9 |
| | 2 | 12 | 4.23 | 0.02 | 4.19 | 4.26 | 0.5 |
| | 3 | 12 | 6.68 | 0.07 | 6.54 | 6.79 | 1.1 |
| Cl | 1 | 12 | 72.5 | 5.3 | 58.0 | 77.0 | 7.3 |
| | 2 | 12 | 91.6 | 6.0 | 73.0 | 97.0 | 6.5 |
| | 3 | 12 | 117.9 | 6.8 | 106.0 | 137.0 | 5.7 |
| Li | 1 | 12 | 0.34 | 0.08 | 0.26 | 0.32 | |
| | 2 | 12 | 1.12 | 0.01 | 1.10 | 1.12 | |
| | 3 | 12 | 2.17 | 0.09 | 2.15 | 2.29 | |

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## Correlation with Medica Fluid Packs

Correlation data were obtained from human serum samples for Na, K, Cl, Ca, and Li. Samples were then spiked to vield varying concentrations of each of the measuring analytes. The serum samples were measured on Medica EasyLytes calibrated with Mission Fluid Packs for 2 runs and Calibrated with Medica Fluid Packs for 2 runs each test day.

Linear regression analysis was performed using Mission data as the independent X variable and Medica as the dependent Y variable in the equation Y = mX +b where m = slope, b = intercept

| Analyte | N | Slope | Intercept | R2 | Range |
|---------|----|-------|-----------|------|--------------|
| Na | 55 | 1.0 | 5.2 | 0.99 | 35.4 - 193.8 |
| K | 55 | 1.0 | 0.03 | 1.00 | 1.80 - 8.61 |
| Cl | 55 | 1.0 | 4.6 | 1.00 | 21.4 - 192.1 |
| Li | 15 | 0.9 | 0.09 | 1.00 | 0.73 - 1.96 |

#### MEDICA Correlation Summary

Mission Fluid Packs are substantially equivalent to Medica Fluid Packs. The Correlations exhibited slopes of 1 and R2 of 1.00 to 0.99.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles connected by flowing lines, resembling a bird in flight.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 2 5 2003

Diamond Diagnostics, Inc. c/o Ms. Linda M. Stundtner Mission Diagnostics 331 Fiske Street Holliston, MA 01746

Re: k031159

Trade/Device Name: Mission Diagnostic Fluid Packs on MEDICA Electrolyte Analyzers Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: April 11, 2003 Received: May 27, 2003

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. 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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## Page 2 -

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). You may obtain other general information on your responsibilities under the Act 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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Page 36 of 49

510(k( Number K031159

Device Name: Mission Diagnostic Fluid Packs on MEDICA Electrolyte Analyzers

### Indication For Use:

- The products encompassed by this request are intended for in-vitro diagnostics use and are ● intended for use in calibrating the electrodes.
- Mission reagents are intended to serve as direct replacements to like named products . manufactured by the OEM.
- The products encompassed are to be handled using normal laboratory precautions. ●

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

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

Division Sign-Off

(Optional format 3-10-98)

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k031/5-9

Prescription Use X