STANDARD A, STANDARD B, STANDARD C, CAL, SLOPE

K013850 · Diamond Diagnostics, Inc. · JIT · Dec 21, 2001 · Clinical Chemistry

Device Facts

• Record ID: K013850
• Device Name: STANDARD A, STANDARD B, STANDARD C, CAL, SLOPE
• Applicant: Diamond Diagnostics, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Dec 21, 2001
• 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 r no products on only as and flushing the sample flow path of the equivalent AVL 98X series Analyzers. AVL Scientific Corp is the Original Equipment Manufacturer (OEM) of the analyzers and the predicate reagents.

Device Story

Mission Diagnostic Reagents are aqueous salt-based solutions designed as direct replacements for AVL-branded reagents used in AVL 98X series electrolyte analyzers. These reagents function as calibrators for electrodes and as flushing agents for the instrument's sample flow path. Used in clinical laboratory settings by trained technicians, the reagents ensure the accuracy of electrolyte measurements (Na, K, Cl, Ca, Li) in human serum samples. By maintaining the calibration of the AVL analyzers, the reagents enable consistent diagnostic output, which healthcare providers use to assess patient electrolyte status and guide clinical decision-making.

Clinical Evidence

Bench testing only. Precision studies were conducted over 9 days, measuring three levels of control materials twice daily on AVL 983, 984, and 985 analyzers. Precision (%CV) ranged from 0.33% to 3.65%. Method comparison studies were performed using human serum samples (n=132-162 per analyte) comparing Mission-calibrated analyzers against AVL-calibrated analyzers. Linear regression analysis (Y=mX+b) showed high correlation (R² values 0.9859–0.999) across all measured analytes (Na, K, Cl, Ca, Li).

Technological Characteristics

Aqueous reagents containing salts to achieve specific analyte concentrations for electrode calibration and flow path flushing. Designed for compatibility with AVL 98X series electrolyte analyzers. No specific materials of construction or sterilization methods are detailed beyond their chemical composition as calibrators.

Indications for Use

Indicated for in-vitro diagnostic use as calibrators and flushing agents for the sample flow path of AVL 98X series electrolyte analyzers. Intended for use by laboratory professionals in clinical settings.

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

• BP0936 Standard A (K013850)
• BP0937 Standard B (K013850)
• BP0938 Standard C (K013850)
• BP0442 Standard B (K013850)
• BP1232 Standard A (K013850)
• BP1218 Standard B (K013850)
• BP1203 Standard A (K013850)
• BP1201 Standard B (K013850)

Submission Summary (Full Text)

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## 510(k) Summary for Mission Diagnostic Reagents on AVL 98X AVL Électrolyte Analyzers

K013850

### Submitter's Name & Address 1.

Mission Diagnostics 331 Fiske St Holliston MA 01746 FAX: [phone]

Establishment Registration Number:

In Process

Date of Preparation:

November 16, 2001

Contact Person:

QA/RA Coordinator

Linda Stundtner

508-429-0450

### Identification of the Device: 2.

| Proprietary/Trade name: | Standard A, Standard B, Standard C, Cal, Slope |
|-------------------------|-----------------------------------------------------------|
| 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 |

### Predicate Device: 3.

Mission claims substantial equivalence to the AVL Calibrators listed below:

| Mission Product | AVL Equivalent |
|-----------------------|-------------------|
| AV-BP0936D Standard A | BP0936 Standard A |
| AV-BP0937D Standard B | BP0937 Standard B |
| AV-BP0938D Standard C | BP0938 Standard C |
| AV-BP0442D Standard B | BP0442 Standard B |
| AV-BP1232D Standard A | BP1232 Standard A |
| AV-BP1218D Standard B | BP1218 Standard B |
| AV-BP1203D Standard A | BP1203 Standard A |
| AV-BP1201D Standard B | BP1201 Standard B |

### 4. Device Description:

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

#### Intended Use: 5.

The reagents are intended for use on equivalent AVL Electrolyte Instruments. AVL is the original r rougents and intended for a of the instruments and the predicate reagents which are necessary for the continued operation and use of the instruments.

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The Mission reagents are intended to serve as direct replacements to like named products manufactured by AVL.

| Reagent Used on Instrument | | | | | | Analytes Measured | | | | | | | | | |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------|----|---------|-------------------|------|-----|---|---|---|---|---|-------|---|
| | દર્ભવ વિદ્વારા તાલુકામાં આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય | દર્ભાવ વિદ્યારા તાલુકામાં આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં મુખ્યત્વે ખેત | દર્ભા | 0વ | est 198 | 12198 | 0214 | にして | | | | | | 家 (彩) | |
| 982 | × | | | X | | | | | × | X | | | | | |
| 983 | × | | | × | | | | | X | × | × | | | | |
| 984 | | | | | × | × | | | × | × | | X | | | |
| ଚିଷ୍ଟର | × | X | × | | | | | | × | X | | | × | | |
| 986 | | | | | | | × | X | × | × | X | | | × | |
| 987 | | | | | × | X | | | X | X | | × | | | × |
| 988-3 | × | × | × | | X | × | | | × | × | X | × | × | | |
| 988-4 | | | | | × | × | | | × | × | | X | | | × |

- Mission uses a similar composition, description and packaging as that used by AVL in its . products, as shown in the packaging section of this submission.
- Performance equivalence was shown in the following manner: .
- Through a method comparison where results obtained on an equivalent AVL o analyzer, calibrated with Mission calibrating products and compared with results obtained on the same analyzer calibrated with AVL calibrating products.
- Through a precision study where Mission products were installed on an equivalent O AVL analyzer and samples were measured minimally twice a day for 9 days.

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 times within a run, two runs minimally per day for nine days on each AVL analyzer calibrated with all Mission reagents.

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# Precison Data Table 1 983 AVL Electrolyte Instrument

Three levels of QC Material, Na, K , CI precision values

| AVL | 983 | Na | | | | |
|-------|---------|-------|--------|-------|-------|-------|
| | Mission | | | | | |
| Level | N | Mean | StdDev | Min | Max | %CV |
| QC1 | 48 | 117.2 | 1.08 | 113.8 | 120.1 | 0.92% |
| QC2 | 44 | 141.7 | 0.60 | 140.3 | 144.4 | 0.42% |
| QC3 | 48 | 166.9 | 0.82 | 165.3 | 169.4 | 0.49% |
| AVL | 983 | K | | | | |
| | Mission | | | | | |
| Level | N | Mean | Stdev | Min | Max | %CV |
| QC1 | 48 | 1.97 | 0.072 | 1.77 | 2.14 | 3.65% |
| QC2 | 45 | 4.32 | 0.031 | 4.20 | 4.39 | 0.72% |
| QC3 | 48 | 7.10 | 0.089 | 6.88 | 7.48 | 1.26% |
| AVL | 983 | Cl | | | | |

| | Mission | | | | | |
|-------|---------|-------|--------|-------|-------|-------|
| Level | N | Mean | StdDev | Min | Max | %CV |
| QC1 | 48 | 84.7 | 2.10 | 80.6 | 90.9 | 2.48% |
| QC2 | 45 | 101.2 | 1.15 | 99.0 | 103.6 | 1.13% |
| QC3 | 48 | 133.8 | 0.89 | 129.8 | 135.7 | 0.66% |

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# Precison Data Table 2 984 AVL Electrolyte Instrument

Three levels of QC Material, Na, K , Ca precision values

| AVL | 984 |
|-----|-----|
|-----|-----|

Na

| | Mission | | | | | |
|-------|---------|-------|--------|-------|-------|-------|
| Level | N | Mean | StdDev | Min | Max | %CV |
| QC1 | 51 | 117.3 | 1.35 | 114.1 | 120.6 | 1.15% |
| QC2 | 49 | 140.9 | 0.90 | 138.4 | 145.0 | 0.64% |
| QC3 | 51 | 165.1 | 1.82 | 155.1 | 170.8 | 1.10% |

AVL 984 K

| | Mission | | | | | |
|-------|---------|------|-------|------|------|-------|
| Level | N | Mean | Stdev | Min | Max | %CV |
| QC1 | 49 | 2.07 | 0.055 | 1.98 | 2.17 | 2.66% |
| QC2 | 49 | 4.34 | 0.025 | 4.29 | 4.41 | 0.58% |
| QC3 | 51 | 7.03 | 0.049 | 6.87 | 7.11 | 0.70% |

AVL 984 Ca

| | Mission | | | | | |
|-------|---------|------|--------|------|------|-------|
| Level | N | Mean | StdDev | Min | Max | %CV |
| QC1 | 50 | 2.00 | 0.034 | 1.91 | 2.09 | 1.72% |
| QC2 | 48 | 1.10 | 0.020 | 1.03 | 1.14 | 1.85% |
| QC3 | 50 | 0.56 | 0.012 | 0.53 | 0.59 | 2.21% |

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# Precison Data Table 3 985 AVL Electrolyte Instrument

Three levels of QC Material, Na, K , Li precision values

| | Mission | | | | | |
|-------|---------|-------|--------|-------|-------|-------|
| Level | N | Mean | StdDev | Min | Max | %CV |
| QC1 | 48 | 118.6 | 1.13 | 116.7 | 121.1 | 0.95% |
| QC2 | 47 | 142.4 | 0.61 | 141.5 | 144.7 | 0.43% |
| QC3 | 48 | 166.5 | 0.55 | 165.3 | 167.7 | 0.33% |

| | Mission | | | | | |
|-------|---------|------|-------|------|------|-------|
| Level | N | Mean | Stdev | Min | Max | %CV |
| QC1 | 48 | 2.07 | 0.067 | 1.98 | 2.22 | 3.23% |
| QC2 | 47 | 4.38 | 0.061 | 4.32 | 4.75 | 1.40% |
| QC3 | 48 | 7.01 | 0.059 | 6.88 | 7.11 | 0.84% |

AVL 985

| | Mission | | | | | | |
|-------|---------|------|--------|------|------|-------|--|
| Level | N | Mean | StdDev | Min | Max | %CV | |
| QC1 | 47 | 0.29 | 0.006 | 0.28 | 0.31 | 2.20% | |
| QC2 | 47 | 0.97 | 0.016 | 0.92 | 1.00 | 1.63% | |
| QC3 | 48 | 2.13 | 0.041 | 2.02 | 2.21 | 1.90% | |

## 510(k) Submission for Mission Diagnostics Reagents on AVL 98X Electrolyte Analyzers

Li

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## Correlation with AVL 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 spiked with Librain a bace in of the measuring analytes. The serum samples were measured on each AVL analyzers calibrated with Mission reagents for 2 runs and Calibrated with AVL reagents for 2 runs each test day.

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

### Correlation Data Table 1

## Regression Analysis of Mission vs AVL Human Serum Results

Y = mX + b where Y = AVL results, X = Mission results, m = Slope, b = Intercept

| | Na | | | | |
|-----|-----|--------|------------|--------|----------|
| | N | Slope | Interecept | R2 | Range |
| 983 | 153 | 0.9859 | 2.13 | 0.9989 | 66 - 178 |
| 984 | 135 | 1.011 | -1.50 | 0.9985 | 66 - 176 |
| 985 | 161 | 1.024 | -3.42 | 0.999 | 67 - 178 |

| K | | | | | |
|-----|-----|--------|-----------|--------|-------------|
| | N | Slope | Intercept | R2 | Range |
| 983 | 153 | 0.9777 | 0.12 | 0.9984 | 2.41 - 6.64 |
| 984 | 135 | 1.0034 | 0.03 | 0.9989 | 2.48 - 6.43 |
| 985 | 162 | 1.0094 | -0.02 | 0.9987 | 2.45 - 6.52 |

| N | Slope | Interecept | R2 | Range | |
|--------|-------|------------|-------|--------|-------------|
| 983 Cl | 151 | 0.9669 | 3.97 | 0.9984 | 52 - 162 |
| 984 Ca | 134 | 0.9004 | 0.07 | 0.9859 | 0.67 - 2.25 |
| 985 Li | 132 | 1.0144 | -0.02 | 0.9940 | 0.33 - 2.55 |

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Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The logo is black and white.

DEC 21 2001

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Diamond Diagnostics, Inc. c/o Ms. Linda M. Studtner QA/RA Coordinator Mission Diagnostics 331 Fiske Street Holliston, MA 01746

Re: k013850

Trade/Device Name: Mission Diagnostic Reagents for AVL 98X Analyzers Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: November 16, 2001 Received: November 20, 2001

Dear Ms Studtner:

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.

{7}------------------------------------------------

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/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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 K013850

Device Name: Mission Diagnostic Reagents for AVL 98X Analyzers

### Indication For Use:

The products encompassed by this request are intended for in-vitro diagnostics use and are intended r no products on only as and flushing the sample flow path of the equivalent AVL 98X series Analyzers. AVL Scientific Corp is the Original Equipment Manufacturer (OEM) of the analyzers and the predicate reagents.

| Mission PN | | 98X AVL Instrument<br>Reagent Used On |
|------------|------------|---------------------------------------|
| Standard A | AV-BP0936D | 982, 983, 985, 988-3 (Cl, Li) |
| Standard B | AV-BP0937D | 985, 988-3 (Cl, Li) |
| Standard B | AV-BP0442D | 982, 983 |
| Standard C | AV-BP0938D | 985, 988-3 (Li) |
| Standard A | AV-BP1232D | 984, 987, 988-3 (Ca), 988-4 |
| Standard B | AV-BP1218D | 984, 987, 988-3 (Ca), 988-4 |
| Standard A | AV-BP1203D | 986 |
| Standard B | AV-BP1201D | 986 |

Mission reagents are intended to serve as direct replacements to like named products manufactured by AVL.

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)

Rx ✓

Sean Cooper
(Division Sign-Off)

510(k) ivumb

(Optional format 3-10-98)

510(k) Submission for Mission Diagnostics Reagents on AVL 98X Electrolyte Analyzers