CALIBRATING MATERIAL, CALIBRATING STANDARDS

K033060 · Diamond Diagnostics, Inc. · JIT · Mar 4, 2004 · Clinical Chemistry

Device Facts

• Record ID: K033060
• Device Name: CALIBRATING MATERIAL, CALIBRATING STANDARDS
• Applicant: Diamond Diagnostics, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Mar 4, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

These calibrators are intended to replace the original equipment manufacturer’s calibrators. Refer to Indications for Use for details. The fifteen Mission Diagnostic calibrator solutions appear in the table below, along with their intended use. PN Product Name Intended Use AV-BP1579D BG Calibrator Provide a second calibration point for the pH and pCO2electrodes on the AVL Compact 1 pH/Blood Gas Analyzer. CD-105670D Hct Slope Provide a second calibration point for the Hct sensor on the 348Analyzer. CD-471818D 634 Ca/pH Slope Standard To provide a second calibration point for the Ca & pH electrodeson the 634 Ca/pH Analyzer. CD-473606D 654 Lithium Slope Solution 2.50 mmol/L To provide a second calibration point for the Lithium electrodeon the 654 Na/K/Li Analyzer. CD-473692D pH Blood Gas Slope To provide a second calibration point for pH, pCO2, and pO2on 238 pH/Blood Gas Analyzer. RD-944015D Calibrating Solution 1, Btl# 9 To provide a calibration point for the Na+, K+, Ca++, Cl-, pH andglucose, lactate electrodes on Radiometer 605, 615, 625, EML100 & 105 Analyzers. RD-944030D Calibrating Solution 1, Btl# 3 To provide a calibration point for the Na+, K+, Ca++, Cl-, pH andglucose, lactate electrodes on Radiometer 605, 615, 625, EML100 & 105 Analyzers. RD-944031D Calibrating Solution 2, Btl# 4 To provide a second calibration point for the Na+, K+, Ca++, Cl-,and pH electrodes on Radiometer 555 Analyzer. BK-465908D Calibrator 1 Used in conjunction with Calibrator 2 and 3 to calibrate Na, K,Cl, Ca, TCO2, Glucose, BUN, & Creatinine on BeckmanSynchron CX Delta, CX®CE, and CX9 ALX Systems. BK-465909D Calibrator 2 Used in conjunction with Calibrator 1 and 3 to calibrate Na, K,Cl, Ca, TCO2, Glucose, BUN, & Creatinine on BeckmanSynchron CX Delta, CX®CE, and CX9 ALX Systems. BK-465910D Calibrator 3 Used in conjunction with Calibrator 1 and 2 to calibrate Na, K,Cl, Ca, TCO2, Glucose, BUN, & Creatinine on BeckmanSynchron CX Delta, CX®CE, and CX9 ALX Systems. BK-443360D Calibration Standard 1 Used in conjunction with Calibration Standard 2 to calibrate Na,K, Cl, Ca, TCO2, Glucose, BUN, & Creatinine on BeckmanSynchron CX3 and CX5 Systems. BK-443365D Calibration Standard 2 Used in conjunction with Calibration Standard 1 to calibrate Na,K, Cl, Ca, TCO2, Glucose, BUN, & Creatinine on BeckmanSynchron CX3 and CX5 Systems. BM-620427D ISE Standard High To provide a calibration point for Na+, K+ and Cl- electrodes onthe ISE module of Hitachi 7xx, 911, 912 and 917 Analyzers. BM-620428D ISE Standard Low To provide a calibration point for Na+, K+ and Cl- electrodes onthe ISE module of Hitachi 7xx, 911, 912 and 917 Analyzers.

Device Story

Mission Diagnostic Reagents are aqueous calibrating solutions containing salts; designed as direct replacements for OEM-specific calibrators. Used in clinical laboratory settings by technicians to calibrate automated analyzers (e.g., AVL, Radiometer, Beckman Synchron, Hitachi). Reagents provide known analyte concentrations to establish calibration points for electrodes; ensuring instrument accuracy for patient sample testing. Healthcare providers use analyzer outputs for diagnostic decision-making. Benefits include continued operation of existing clinical instrumentation using cost-effective, equivalent replacement reagents.

Clinical Evidence

No clinical data. Bench testing only. Value assignment performed by comparing recovery against OEM calibrator material or NIST standards. Stability studies (accelerated and real-time) conducted to verify concentration maintenance within specified tolerances over time.

Technological Characteristics

Liquid, ready-to-use aqueous salt solutions; tonometered with gas for blood gas analytes. Form factor: Vials. No energy source. Standalone use for instrument calibration. No software or algorithm involved.

Indications for Use

Indicated for in-vitro diagnostic use as calibrators for specific OEM pH, blood gas, and electrolyte analyzers to provide calibration points for various electrodes including Na+, K+, Cl-, Ca++, pH, pCO2, pO2, Hct, glucose, lactate, TCO2, BUN, and creatinine.

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

• BG Calibrator (K943570)
• Hct Slope (K962021)
• 634 Slope Standard (K844188)
• 654 Lithium Slope Solution 2.50 mmol/L (K884769)
• pH Blood Gas Slope (K904188)
• Calibrating Solution 1, Btl# 9 (K954612)
• Calibrating Solution 1, Btl# 3 (K973367)
• Calibrator 2 (K942676)
• Calibration Standard 1 (K864236)
• ISE Standard High (K811194)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE

A. 510(k) Number:
k033060

B. Analyte:
pH, PCO2, PO2, TCO2, Sodium, Potassium, Calcium, Chloride, Lithium, Glucose, Lactate, Creatinine, Urea, Hematocrit

C. Type of Test:
Calibrators

D. Applicant:
Diamond Diagnostics, Inc., Mission Diagnostics Division

E. Proprietary and Established Names:
See table below under Indications for Use (G,2) for proprietary names

F. Regulatory Information:
1. Regulation section:
862.1150, Calibrator, secondary
2. Classification:
Class II
3. Product Code:
JIT
4. Panel:
Chemistry (75)

G. Intended Use:
1. Intended use(s):
These calibrators are intended to replace the original equipment manufacturer’s calibrators. Refer to Indications for Use for details.
2. Indication(s) for use:
The fifteen Mission Diagnostic calibrator solutions appear in the table below, along with their intended use.

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| PN | Product Name | Intended Use |
| --- | --- | --- |
| AV-BP1579D | BG Calibrator | Provide a second calibration point for the pH and pCO2electrodes on the AVL Compact 1 pH/Blood Gas Analyzer. |
| CD-105670D | Hct Slope | Provide a second calibration point for the Hct sensor on the 348Analyzer. |
| CD-471818D | 634 Ca/pH Slope Standard | To provide a second calibration point for the Ca & pH electrodeson the 634 Ca/pH Analyzer. |
| CD-473606D | 654 Lithium Slope Solution 2.50 mmol/L | To provide a second calibration point for the Lithium electrodeon the 654 Na/K/Li Analyzer. |
| CD-473692D | pH Blood Gas Slope | To provide a second calibration point for pH, pCO2, and pO2on 238 pH/Blood Gas Analyzer. |
| RD-944015D | Calibrating Solution 1, Btl# 9 | To provide a calibration point for the Na+, K+, Ca++, Cl-, pH andglucose, lactate electrodes on Radiometer 605, 615, 625, EML100 & 105 Analyzers. |
| RD-944030D | Calibrating Solution 1, Btl# 3 | To provide a calibration point for the Na+, K+, Ca++, Cl-, pH andglucose, lactate electrodes on Radiometer 605, 615, 625, EML100 & 105 Analyzers. |
| RD-944031D | Calibrating Solution 2, Btl# 4 | To provide a second calibration point for the Na+, K+, Ca++, Cl-,and pH electrodes on Radiometer 555 Analyzer. |
| BK-465908D | Calibrator 1 | Used in conjunction with Calibrator 2 and 3 to calibrate Na, K,Cl, Ca, TCO2, Glucose, BUN, & Creatinine on BeckmanSynchron CX Delta, CX®CE, and CX9 ALX Systems. |
| BK-465909D | Calibrator 2 | Used in conjunction with Calibrator 1 and 3 to calibrate Na, K,Cl, Ca, TCO2, Glucose, BUN, & Creatinine on BeckmanSynchron CX Delta, CX®CE, and CX9 ALX Systems. |
| BK-465910D | Calibrator 3 | Used in conjunction with Calibrator 1 and 2 to calibrate Na, K,Cl, Ca, TCO2, Glucose, BUN, & Creatinine on BeckmanSynchron CX Delta, CX®CE, and CX9 ALX Systems. |
| BK-443360D | Calibration Standard 1 | Used in conjunction with Calibration Standard 2 to calibrate Na,K, Cl, Ca, TCO2, Glucose, BUN, & Creatinine on BeckmanSynchron CX3 and CX5 Systems. |
| BK-443365D | Calibration Standard 2 | Used in conjunction with Calibration Standard 1 to calibrate Na,K, Cl, Ca, TCO2, Glucose, BUN, & Creatinine on BeckmanSynchron CX3 and CX5 Systems. |
| BM-620427D | ISE Standard High | To provide a calibration point for Na+, K+ and Cl- electrodes onthe ISE module of Hitachi 7xx, 911, 912 and 917 Analyzers. |
| BM-620428D | ISE Standard Low | To provide a calibration point for Na+, K+ and Cl- electrodes onthe ISE module of Hitachi 7xx, 911, 912 and 917 Analyzers. |

3. Special condition for use statement(s):

The devices are for in vitro diagnostic use.

The devices are for prescription use.

4. Special instrument Requirements:

Not applicable.

# H. Device Description:

The products are liquid, ready to use. They consist of salts added to deionized water and, as needed, tonometered gas.

# I. Substantial Equivalence Information:

1. Predicate device name(s):

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# Substantial Equivalence Table of Product PN's & Trade Names – Mission vs OEM

| | Mission Diagnostics | | OEM* Equivalent | | | |
| --- | --- | --- | --- | --- | --- | --- |
| # | | | Predicate Device | | | Cleared Date |
| 1 | AV-BP1579D | BG Calibrator | BP1579 | BG Calibrator | K943570 | 08-24-1994 |
| 2 | CD-105670D | Hct Slope | 105670 | Hct Slope | K962021 | 06-24-1996 |
| 3 | CD-471818D | 634 Ca/pH Slope Standard | 471818 | 634 Slope Standard 2.50^{Ca}/6.84^{pH} | K844188 | 11-23-1988 |
| 4 | CD-473606D | 654 Lithium Slope Solution 2.50 mmol/L | 473606 | 654 Lithium Slope Solution 2.50 mmol/L | K884769 | 01-17-1989 |
| 5 | CD-473692D | pH Blood Gas Slope | 473692 | pH Blood Gas Slope | K904188 | 09-27-1990 |
| 6 | RD-944015D | Calibrating Solution 1, Btl# 9 | 944015 | Calibrating Solution 1, Btl# 9 | K954612 | 11-09-1995 |
| 7 | RD-944030D | Calibrating Solution 1, Btl# 3 | 944030 | Calibrating Solution 1, Btl# 3 | K973367 | 10-06-1997 |
| 8 | RD-944031D | Calibrating Solution 2, Btl# 4 | 944031 | Calibrating Solution 2, Btl# 4 | | |
| 9 | BK-465908D | Calibrator 1 | 465908 | Calibrator 1 | K942676 | 11-02-1994 |
| 10 | BK-465909D | Calibrator 2 | 465909 | Calibrator 2 | | |
| 11 | BK-465910D | Calibrator 3 | 465910 | Calibrator 3 | | |
| 12 | BK-443360D | Calibration Standard 1 | 443360 | Calibration Standard 1 | K864236 | 12-31-1986 |
| 13 | BK-443365D | Calibration Standard 2 | 443365 | Calibration Standard 2 | | |
| 14 | BM-620427D | ISE Standard High | 620427 | ISE Standard High | K811194 | 05-27-1981 |
| 15 | BM-620428D | ISE Standard Low | 624028 | ISE Standard Low | | |

* OEM = Original Equipment Manufacturer

2. Predicate K number(s):
See the table in section I, 1, above.

3. Comparison with predicate:
In all cases the sponsor states that the products are manufactured to the same specifications of the original equipment manufactured products, including the type of vial that holds the material. The devices are made by different manufacturers.

J. Standard/Guidance Document Referenced (if applicable):
The sponsor did not reference any standard in this submission.

K. Test Principle:
Not applicable.

L. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Not applicable.
b. Linearity/assay reportable range:
Not applicable.

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c. Traceability (controls, calibrators, or method):

The appropriate salts (chemical constituents) are gravimetrically weighed and added to Type 1 deionized water to yield the desired calibration values. The calibrators are tonometered with the appropriate gas to yield the desired pH, pCO2, and pO2 levels for each control.

VALUE ASSIGNMENT:

In general, manufactured calibrators are tested on 1-2 instruments within their facility to evaluate their recovery against the OEM calibrator material, or a previous Mission lot. A bias between the manufactured product and the calibrator is established and values are adjusted. Alternately, if NIST material is used, then values are normalized to that standard. Details of the calibrating materials and methods used are summarized below.

Na NIST 919a NaCl, using the flame photometer
K NIST 918a KCl, using the flame photometer
pH BG Calibrator BP1579, pH/Blood Gas Slope 473692 calibrator, Radiometer Calibrating Sol. 1 Btl #3, Radiometer Calibrating Sol. 2 Btl #4, or previous Mission Lot BG Calibrator, using the Corning 278 and 288 analyzers (or equivalent)
pCO2 BG Calibrator BP1579, pH/Blood Gas Slope 473692 calibrator, or previous Mission Lot BG Calibrator, using the Corning 278 and 288 analyzers (or equivalent)
TCO2 Beckman Calibrator 3 465910, Beckman Calibration Standard 2 443365, or previous Mission calibrator, run on the CX3 or Delta system.
pO2 BG Calibrator BP1579, pH/Blood Gas Slope 473692 calibrator, or previous Mission Lot BG Calibrator, using the Corning 278 and 288 analyzers (or equivalent)
Ca NIST 915a Ca2CO3, Corning 288 ISE Ca or 634 ISE Ca (or equivalent) or, depending on the calibrator the Beckman Calibrator 1 465908 or previous Mission calibrator on the CX3 or CX Delta System, or the Beckman Calibrator 2 465909 or previous Mission calibrator run on the CX3 or CX Delta analyzer
Cl NIST 919a NaCl, run on Corning 664 ISE Cl or 925 Chloridometer or equivalent
Hct Commercially available standards such as Thermo Orion 011007 1413 $\mu$S/cm &011006 12.9 mS/cm, Hct Slope 105670, or previous Mission calibrator, or conductivity standards (that are not specified), testing performed on a

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conductivity meter and Corning 348 Analyzer (or equivalent)

Li IL Standard 02221350, using a flame photometer

Lactate Commercially available kit such as SIGMA 115A or Radiometer Calibrating Sol 1 Btl #9 (or #3, depending on the calibrator), or previous Mission calibrator, run by a manual assay.

Glucose Commercially available kit such as SIGMA 826A, Radiometer Calibrating Sol. 1 Btl #9, or previous Mission calibrator, run by a manual assay, or, depending on the calibrator the Beckman Calibrator 1 465908, Beckman Calibration Standard 1 443360, or previous Mission calibrator on the CX3 or CX Delta System, or the Beckman Calibrator 2 465909 or previous Mission calibrator run on the CX3 or CX Delta analyzer

Creat Beckman Calibrator 1 465908 or previous Mission calibrator on the CX3 or CX Delta System, or, depending on the calibrator the Beckman Calibrator 2 465909 or previous Mission calibrator run on the CX3 or CX Delta analyzer

BUN Beckman Calibrator 1 465908 or previous Mission calibrator on the CX3 or CX Delta System, or, depending on the calibrator the Beckman Calibrator 2 465909, Beckman Calibration Standard 1 443360, or previous Mission calibrator run on the CX3 or CX Delta analyzer

## Summaries of the value assignment procedures are as follows:

For Na, K, Cl, Ca, Li (and pH for some of the calibrators) representative samples from the lot (the number of samples is not specified) are run along with NIST standards in a single run. Three replicates of each sample are run on one instrument. Values are normalized to match the standard.

For Glucose, Lactate, BUN, Creatinine, TCO2 (and Ca, depending on the calibrator) representative samples (the number is not specified) of the lot are tested in 1 run along with the calibrator. Samples are run in duplicate (or triplicate, depending on the calibrator) according to the assay's instructions. The means and SDs are calculated and normalized to the calibrator.

For pH, PCO2, and pO2 the testing is done on 2 instruments. During the tonometry process, ampules are monitored every 5-7 minutes (or every 10-15 minutes depending on the calibrator) to ensure they remain within established limits; the pCO2 mean value

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of the replicate measurements is within 1 (or 1.5 depending on the calibrator) and the pO2 is within 8 (or 7 depending on the calibrator) mm/Hg of the calibrating material. No limit is identified for pH.

For Hct, conductivity of the calibrator is measured in duplicate on a single conductivity meter. The mean of the duplicates is compared to specifications (which are not provided by the sponsor). If they pass, they are tested on the Corning 348 Analyzer. If the samples do not pass specifications (not provided) then the lot is adjusted and retested.

## STABILITY:

Accelerated and real time stability studies are summarized for the calibrators. The sponsor specifies the concentrations of materials evaluated in the studies, the frequency of testing, the method for testing the materials, environmental conditions of storage, and acceptance criteria for the study. One lot of each product is evaluated in accelerated studies and 3 lots are evaluated in real time studies, then stability studies are not done again. Acceptance criteria when compared to time zero are:

Na within 2.0 (or 1.0 depending on calibrator) mmol/L

K within 0.05 (0.2 or 3.0, depending on the calibrator) mmol/L

Li within 0.05 mmol/L

pH within 0.005 (or 0.01 or 0.02 or 0.008 depending on the calibrator)

pCO2 within 3 (or 5 depending on the calibrator) mm/Hg

pO2 within 10 mm/Hg

TCO2 within 2 mmol/L

Hct within 15 mS/cm

Ca within 0.05 (or 0.03, 0.2 or 0.12 depending on the calibrator) mmol/L, or 0.8 mg/dL

Cl within 3 (or 2 depending on the calibrator) mmol/L

Glucose within 0.4 mmol/L (or within 3, 3.5 or 5 mg/dL depending on the calibrator)

Lactate within 0.2 mmol/L

Creat within 0.2 (1.0 or 2.0 depending on the calibrator) mg/dL

BUN within 1.0 (2.0 or 3.0 depending on the calibrator) mg/dL

d. Detection limit:

Not applicable.

e. Analytical specificity:

Not applicable.

f. Assay cut-off:

Not applicable.

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2. Comparison studies:
a. Method comparison with predicate device:
Not applicable. The sponsor did, however, run a series of spiked serum samples and analyzed them using their calibrator and several of the OEM calibrators. The data appears in their 510k Summary.
b. Matrix comparison:
Not applicable.

3. Clinical studies:
a. Clinical sensitivity:
Not applicable.
b. Clinical specificity:
Not applicable.
c. Other clinical supportive data (when a and b are not applicable):

4. Clinical cut-off:
Not applicable.

5. Expected values/Reference range:
Representative target concentrations for the calibrators have been provided.

M. Conclusion:
I recommend that this device be found substantially equivalent to the predicate device.