CALIBRATING MATERIAL, ISE ELECTROLYTE REFERENCE
Device Facts
| Record ID | K033061 |
|---|---|
| Device Name | CALIBRATING MATERIAL, ISE ELECTROLYTE REFERENCE |
| Applicant | Diamond Diagnostics, Inc. |
| Product Code | JIX · Clinical Chemistry |
| Decision Date | Nov 7, 2003 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1150 |
| Device Class | Class 2 |
Intended Use
The three products encompassed by this request are intended for in-vitro diagnostics use. Mission Electrolyte Reference Reagent provides reference points for Na, K, CI, Ca (on Delta's only) and TCO2. When used in conjunction with CO2 Acid Reagent, CO2 Alkaline Buffer and Electrolyte Buffer, the ISE Electrolyte Reference is used for the calibration of the ISE electrodes; sodium, potassium chloride and calcium (on Delta's only) and CO2. The CO2 Acid reagent is used to release CO2 from samples. The CO2 Alkaline in used to provide a constant CO2 concentration as reference for the CO2 electrode. Mission reagents are intended to serve as direct replacements to the predicate devices manufactured by the OEM. The products encompassed are to be handled using normal laboratory precautions.
Device Story
The device consists of three liquid reagents (CO₂ Alkaline Buffer, CO₂ Acid Reagent, and ISE Electrolyte Reference) used as calibrators for Beckman Synchron CX® and CX® Delta clinical chemistry analyzers. These reagents provide reference points for Na, K, Cl, Ca, and TCO2 measurements. The CO₂ Acid reagent releases CO2 from samples; the Alkaline buffer provides a constant CO2 reference; the ISE Electrolyte Reference provides reference points for electrolytes. The device is used in clinical laboratory settings by trained laboratory personnel. It serves as a direct replacement for OEM reagents. By calibrating the analyzer, the device ensures the accuracy of patient sample measurements, which healthcare providers use to diagnose and monitor electrolyte and acid-base status.
Clinical Evidence
No clinical studies were performed. Evidence consists of analytical bench testing. Precision was evaluated on CX® Delta and CX®3 analyzers; total precision CVs ranged from 0.29% to 8.97% across analytes. Method comparison studies against the predicate device showed high correlation (R² 0.991–0.998) for CO2, Chloride, Potassium, and Sodium. Traceability was established via NIST standards and OEM calibrators.
Technological Characteristics
Multi-analyte liquid calibrator set. CO₂ Alkaline buffer: 6 mmol/L potassium bicarbonate, 10 mmol/L potassium chloride, buffer, dye, surfactant, preservative (pH 8.8). CO₂ Acid reagent: 6 mmol/L sulfuric acid, preservative. ISE Electrolyte Reference: 140 mmol/L sodium, 4 mmol/L potassium, 100 mmol/L chloride, 10 mmol/L total CO₂, 2 mmol/L calcium, buffer, surfactant, preservative. Gravimetric preparation. Traceable to NIST standards and OEM calibrators.
Indications for Use
Indicated for use as a multi-analyte calibrator for the Beckman Synchron CX® and CX® Delta clinical chemistry systems to provide reference points for sodium, potassium, chloride, calcium, and total CO2 measurements.
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
- CO2 Alkaline Buffer (443320) (K942676)
- CO2 Acid (443330) (K942676)
- ISE Electrolyte Reference (450214) (K864236)
Related Devices
- K020364 — PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS · Phoenix Diagnostics, Inc. · Jun 4, 2002
- K052724 — TECO ISE REAGENT SET FOR CX SYSTEM · Teco Diagnostics · Dec 14, 2005
- K982501 — ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44 · Alko Diagnostic Corp. · Sep 1, 1998
Submission Summary (Full Text)
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K033061
NOV - 7 2003
# Summary of 510(k) Submission for Mission ISE Reference & CO2 Reagents for Beckman Synchron Delta & CX® Systems
| <b>1. Submitter's Name & Address</b><br>Mission Diagnostics<br>331 Fiske St<br>Holliston MA 01746<br>FAX: 508-429-0452 | <b>Contact Person</b><br>Linda Stundtner<br>QA/RA Manager<br>508-429-0450 |
|----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Establishment Registration Number: 3003656721 | |
Date of Preparation:
Sept 22, 2002
## 2. Identification of the Device:
| Proprietary/Trade name: | Calibrating Material, Reference Buffer |
|-------------------------|----------------------------------------|
| Common or usual name | Calibrators for ISE automated systems |
| Classification name: | Calibrator, secondary |
| Device Classification | II |
| Regulation Number: | 21 CFR § 862.1150 |
| Panel: | Chemistry (75) |
| Product Code: | JIT |
- Mission manufactures calibrators intended to serve as direct replacements to like named . products (predicate devices) manufactured by Original Equipment Manufactures (OEM)
#### 3. Predicate Device:
- Mission claims substantial equivalence to the OEM Materials listed below: .
## Substantial Equivalence Table of Product PN's & Trade Names
| Mission Product | OEM Equivalent | | |
|-----------------|---------------------------|--------|---------------------------|
| BK-443320D | CO2 Alkaline Buffer | 443320 | CO2 Alkaline Buffer |
| BK-443330D | CO2 Acid | 443330 | CO2 Acid |
| BK-450214D | ISE Electrolyte Reference | 450214 | ISE Electrolyte Reference |
- . The predicate reagents are encompassed in the 510(k)'s K942676 & K864236 cleared 11/02/1994 & 12/31/1986 respectively.
## 4. Device Description:
- The Calibrators for the OEM Instruments are aqueous reagents with salts added to obtain . desired analyte levels to provide calibration of the electrodes.
- Intended Use: ●
- . The reagents are intended for use on equivalent OEM Instruments.
510k for Mission ISE Reference & CO2 Reagents on Beckman Synchron Delta & CX® Systems
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- . The original equipment manufacturer (OEM) of the instruments and the predicate reagents 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.
- . Performance equivalence is shown in the following manner:
- . Through a method comparison where results obtained on an equivalent OEM analyzer, calibrated with Mission calibrating material are compared with results obtained on the same analyzer calibrated with OEM calibrating material.
- . A summary of the results of these studies follows:
## 5. Performance Characteristics:
Precision and correlation data are collected per:
- . SOP23-01-02 Performance Study Protocol for 510(k) Submission
- Data for each instrument and each run are recorded on SOP23-03F Performance Study . Record Sheet. (See Attachment Section for Copy of Procedures)
All analytes tested passed criteria per SOP23-01-02 Performance Study Protocol for 510(k) Submission and performed equally to the OEM.
Testing was performed on CX® Delta and CX® depending on availability.
## Table of Precision of Serum Controls, CSF Controls & Urine Controls on CX® Delta
| Analyte | Level | N | Mean | Sd | Min | Max | %CV |
|---------------|----------|----|-------|------|-------|-------|------|
| Na<br>mmol/L | DCtrol 1 | 43 | 142.0 | 6.4 | 129.6 | 157.0 | 4.5 |
| | DCtrol 2 | 38 | 155.7 | 6.9 | 148.7 | 174.4 | 4.4 |
| K<br>mmol/L | DCtrol 1 | 43 | 4.22 | 0.22 | 3.88 | 4.71 | 5.10 |
| | DCtrol 2 | 45 | 8.10 | 0.37 | 7.69 | 9.21 | 4.59 |
| Cl<br>mmol/L | DCtrol 1 | 43 | 107 | 5 | 98 | 118 | 4 |
| | DCtrol 2 | 38 | 118 | 5 | 113 | 131 | 4 |
| Ca<br>mmol/L | DCtrol 1 | 31 | 2.51 | 0.08 | 2.39 | 2.69 | 3.06 |
| | DCtrol 2 | 27 | 3.35 | 0.18 | 3.16 | 4.00 | 5.23 |
| CO2<br>mmol/L | DCtrol 1 | 40 | 14.8 | 0.7 | 13.1 | 16.0 | 4.4 |
| | DCtrol 2 | 43 | 25.4 | 1.1 | 23.1 | 28.2 | 4.2 |
| Na<br>mmol/L | CSF 1 | 13 | 127.4 | 6 | 119.4 | 139.0 | 3.8 |
| | CSF 2 | 12 | 159.9 | 5 | 153.8 | 170.3 | 4.9 |
| Cl<br>mmol/L | CSF 1 | 13 | 89 | 4 | 84 | 95 | 4 |
| | CSF 2 | 12 | 105 | 3 | 102 | 111 | 3 |
| Na<br>mmol/L | URINE 1 | 48 | 65.6 | 4.9 | 59.7 | 77.0 | 7.5 |
| | URINE 2 | 44 | 208.2 | 7.9 | 197.1 | 227.8 | 3.8 |
| K<br>mmol/L | URINE 1 | 48 | 33.7 | 2.2 | 31.5 | 39.0 | 6.4 |
| | URINE 2 | 45 | 108.4 | 6.1 | 101.4 | 122.9 | 5.6 |
| Cl<br>mmol/L | URINE 1 | 47 | 100 | 6 | 92 | 113 | 6 |
| | URINE 2 | 47 | 256 | 10 | 245 | 280 | 4 |
| Ca<br>mmol/L | URINE 1 | 29 | 1.57 | 0.14 | 1.44 | 1.90 | 8.97 |
| | URINE 2 | 32 | 3.50 | 0.14 | 3.27 | 3.84 | 3.99 |
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| Analyte | Level | N | Mean | Sd | Min | Max | %CV |
|-----------|--------|----|------|------|------|------|-----|
| Ca mmol/L | Normal | 18 | 2.42 | 0.06 | 2.30 | 2.52 | 2.5 |
| | Lo | 18 | 1.96 | 0.06 | 1.86 | 2.05 | 3.1 |
| | High | 18 | 3.65 | 0.13 | 3.47 | 3.84 | 3.6 |
# Table of Precision of Serum Samples on CX® Delta
## Table of Precision of Serum Controls on CX®
| Analyte | Level | N | Mean | Sd | Min | Max | %CV |
|------------|----------|----|-------|------|-------|-------|------|
| Na mmol/L | DCtrol 1 | 18 | 139.7 | 0.08 | 138.5 | 141.1 | 0.6 |
| Na mmol/L | DCtrol 2 | 18 | 154.1 | 1.03 | 152.6 | 156.0 | 0.7 |
| K mmol/L | DCtrol 1 | 14 | 4.07 | 0.01 | 4.05 | 4.08 | 0.29 |
| K mmol/L | DCtrol 2 | 12 | 7.36 | 0.03 | 7.89 | 7.98 | 0.42 |
| Cl mmol/L | DCtrol 1 | 18 | 104 | 0.5 | 103 | 105 | 0.5 |
| Cl mmol/L | DCtrol 2 | 18 | 118 | 0.8 | 116 | 120 | 0.7 |
| CO2 mmol/L | DCtrol 1 | 18 | 14.8 | 0.2 | 14.4 | 15.1 | 1.4 |
| CO2 mmol/L | DCtrol 2 | 18 | 26.5 | 0.3 | 25.7 | 27.1 | 1.3 |
# Table of Correlation – Serum Values on CX®
| Analyte | N | Slope | Intercept | R2 | Range |
|---------|----|-------|-----------|-------|--------------|
| Na | 62 | 0.95 | 3.59 | >0.99 | 95.4 - 203.4 |
| K | 91 | 0.99 | -0.03 | >0.99 | 1.81 - 8.79 |
| Cl | 76 | 0.97 | 1.49 | >0.99 | 54 - 203 |
| CO2 | 76 | 0.93 | 1.58 | >0.99 | 8 - 30.7 |
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Image /page/3/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" around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping profiles, creating a sense of depth and movement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV - 7 2003
Diamond Diagnostics, Inc. c/o Ms. Linda M. Stundtner QA/RA Manager Mission Diagnostics 331 Fiske Street Holliston, MA 01746
Re: k033061
> Trade/Device Name: Mission Diagnostic ISE Reference & CO2 Reagents for Beckman Synchron Delta & CX® Systems
Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: September 22, 2003 Received: September 29, 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, 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 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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Butman
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 K033041
Device Name:
Mission Diagnostic ISE Reference & CO2 Reagents for Beckman Synchron Delta & CX® Systems
### Indication For Use:
- The three products encompassed by this request are intended for in-vitro diagnostics use. ●
| Mission Product | |
|-----------------|---------------------------|
| BK-443320D | CO2 Alkaline Buffer |
| BK-443330D | CO2 Acid |
| BK-450214D | ISE Electrolyte Reference |
- Mission Electrolyte Reference Reagent provides reference points for Na, K, CI, Ca (on Delta's only) and . TCO2. When used in conjunction with CO2 Acid Reagent, CO2 Alkaline Buffer and Electrolyte Buffer, the ISE Electrolyte Reference is used for the calibration of the ISE electrodes; sodium, potassium chloride and calcium (on Delta's only) and CO2.
- The CO2 Acid reagent is used to release CO2 from samples .
- The CO2 Alkaline in used to provide a constant CO2 concentration as reference for the CO2 electrode. .
- Mission reagents are intended to serve as direct replacements to the predicate devices 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)
Carol Benson for Jean Cooper, OVM
Division Sign-Off
o Diagnostic De ation and 22
510(k) K033061
(Optional format 3-10-98)
