(41 days)
BP0136, BP0137, 473691, 473496, 104227, 478855D, 478856D, 478864D, 478865D, 473385D, 473386D, 473387D, 570096D
Not Found
No
The summary describes calibrators and reagents for in-vitro diagnostic analyzers, focusing on chemical composition and performance equivalence to OEM products. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is intended for in-vitro diagnostics use, specifically for cleaning and flushing sample flow paths and calibrating OEM analyzers, not for treating any medical condition or disease.
No
The device description indicates that the products are "aqueous reagents" intended to "provide calibration of the electrodes and rinse the sample path" of OEM analyzers. They are replacements for existing OEM products, serving to enable the continued operation of diagnostic instruments, rather than being diagnostic devices themselves. The "Intended Use / Indications for Use" states they are "intended for in-vitro diagnostics use" and are for "schooling and flushing the sample flow path of the equivalent OEM Analyzers," which further clarifies their role as components used with diagnostic devices, not diagnostic devices themselves.
No
The device description clearly states the products are "aqueous reagents with salts added" and are intended for "in-vitro diagnostics use." This indicates a physical, chemical product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The products encompassed by this request are intended for in-vitro diagnostics use..."
- Function: The device is described as "aqueous reagents with salts added to obtain desired analyte levels to provide calibration of the electrodes and rinse the sample path of the equivalent OEM Analyzers." This function of calibrating and rinsing the sample path of analyzers used for testing biological samples (like human serum) is a core activity within in vitro diagnostics.
- Context: The performance studies involve testing human serum samples and control materials on analyzers that measure analytes like pH, pO2, pCO2, Na, K, Ca, Cl, and tCO2. These are common measurements performed in clinical laboratories for diagnostic purposes.
- Predicate Devices: The listed predicate devices are all buffers and calibrators for blood gas and electrolyte analyzers, which are classic examples of IVD devices.
Therefore, based on the provided text, the device is clearly intended for and functions within the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The products encompassed by this request are intended for in-vitro diagnostics use and are intended for r ne products chooling and flushing the sample flow path of the equivalent OEM Analyzers. 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.
Product codes
JIT
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 and rinse the sample path. 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.
The reagents are intended for use on equivalent OEM Instruments.
The original equipment manufacturer (OEM) of the instruments and the predicate reagents which are necessary for the continued operation and use of the instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance equivalence is shown 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.
Precision Data: Precision data are collected from the analysis of three levels of control materials tested over a minimum of 7 days on each OEM analyzer. Analyzers are calibrated with Mission reagents and alternately with the OEM reagents for testing. Precision data tables were provided for the following analyzers:
- 238 Ciba-Corning pH/BG Analyzer (pH, pO2, pCO2)
- 248 Ciba-Corning pH/BG Analyzer (pH, pO2, pCO2)
- 248 Ciba-Corning pH/BG & Electrolyte Analyzer (Na, K, Ca, pH)
- 664 Ciba-Corning Analyzer (Na, K, Cl, tCO2)
- 288 Ciba-Corning pH/BG & Electrolyte Analyzer (Na, K, Ca, pH)
Correlation with OEM Reagents:
Correlation data for electrolytes (Na, K, Cl, Ca) on the 348 were obtained from human serum samples. Samples were spiked with Human Serum Albumin to yield varying concentrations of each of the measuring analytes. The serum samples were measured on the 348 analyzer calibrated with Mission reagents for 1 run and 1 comparison run with OEM reagents each test day. Correlation for pH were obtained by comparing 3 levels of QC.
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.
Correlations demonstrated slopes of 1 and R^2's of 0.99, which support a claim of substantial equivalence.
Regression Analysis of Mission vs OEM; Human Serum Results were provided for Na (N=348, 288, 664), K (N=348, 288, 664), and Ca (N=348, 288).
Regression Analysis of Mission vs OEM; QC Results were provided for pH (N=238, 248, 348, 288).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision:
238 Ciba-Corning pH/BG Analyzer
pH: %CV range 0.1%-0.2%
pO2: %CV range 1.2%-3.7%
pCO2: %CV range 1.6%-2.7%
248 Ciba-Corning pH/BG Analyzer
pH: %CV range 0.0%-0.1%
pO2: %CV range 1.1%-4.6%
pCO2: %CV range 0.7%-1.3%
248 Ciba-Corning pH/BG & Electrolyte Analyzer (renamed 348)
Na: %CV range 1.5%-1.9%
K: %CV range 0.8%-1.3%
Ca: %CV range 4.1%-10.4%
pH: %CV range 0.1%-0.4%
664 Ciba-Corning Analyzer
Na: %CV range 0.6%-1.3%
K: %CV range 0.9%-1.3%
Cl: %CV range 5.6%-8.0%
tCO2: %CV range 3.6%-4.6%
288 Ciba-Corning pH/BG & Electrolyte Analyzer (renamed 200 Series)
Na: %CV range 0.5%-0.7%
K: %CV range 0.6%-1.1%
Ca: %CV range 1.0%-2.8%
pH: %CV range 0.1%-0.2%
Correlation (R2, Slope, Intercept):
Regression Analysis of Mission vs OEM; Human Serum Results:
Na: R2=0.99-1.00, Slope=0.95-1.02
K: R2=1.00, Slope=1.00-1.04
Ca: R2=0.99, Slope=0.96-1.00
Regression Analysis of Mission vs OEM; QC Results:
pH: R2=0.99-1.00, Slope=0.98-1.01
Predicate Device(s)
BP0136 Type 1 Buffer 7.383 AVL, BP0137 Type 2 Buffer 6.841 AVL, 473691 pH/Blood Gas pH 7.38 Cal, 473496 6.8/7.3 Buffer for 248, 104227 6.8/7.3 Buffer for 348, 478855D Ciba-Corning 200 Series 7.3, 478856D Ciba-Corning 200 Series 6.8, 478864D Ciba-Corning 664 Cal/Wash, 478865D Ciba-Corning 664 Slope, 473385D Bayer 800 Series 7.3/Co-ox Zero, 473386D Bayer 800 Series 6.8 Buffer, 473387D Bayer 800 Series Wash/Cal G/L Zero, 570096D Bayer 800 Series Cal G/L
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1150 Calibrator.
(a)
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.)(b)
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.
0
APR 2 9 2002
Page 49 of 70
510(k) Submission for Mission Diagnostic Reagents on pH/Blood Gas &/or Electrolyte Analyzers
| 1. Submitter's Name & Address | Mission Diagnostics |
|---|---|
| 331 Fiske St | |
| Holliston MA 01746 | |
| FAX: 508-429-0452 | |
| Establishment Registration Number: | In Process |
| Date of Preparation: | March 18, 2002 |
| Contact Person: | Linda Stundtner |
| QA/RA Manager | |
| 508-429-0450 |
| 2. Identification of the Device: | |
|---|---|
| Proprietary/Trade name: | Calibrating Material, Cal-Pak, Buffers |
| 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) |
- . Mission manufactures calibrators intended to serve as direct replacements to like named products manufactured by Original Equipment Manufactures (OEM)
Predicate Device: 3.
Product Code:
- Mission claims substantial equivalence to the OEM Calibrating Materials listed below: .
JIT
| Mission Product | OEM Equivalent |
|---|---|
| AV-BP0136D Type 1 Buffer 7.383 | BP0136 Type 1 Buffer 7.383 AVL |
| AV-BP0137D Type 2 Buffer 6.841 | BP0137 Type 2 Buffer 6.841 AVL |
| CD-473691AD Cal-Pak for Ciba-Corning 238 | 473691 pH/Blood Gas pH 7.38 Cal |
| CD-473496AD Cal-Pak for Ciba-Corning 248 | 473496 6.8/7.3 Buffer for 248 |
| CD-104227AD Cal-Pak for Ciba-Corning 348 | 104227 6.8/7.3 Buffer for 348 |
| CD-478855D Ciba-Corning 200 Series 7.3 Buffer | 478855D Ciba-Corning 200 Series 7.3 |
| CD-478856D Ciba-Corning 200 Series 6.8 Buffer | 478856D Ciba-Corning 200 Series 6.8 |
| CD-478864D Ciba-Corning 664 Cal/Wash | 478864D Ciba-Corning 664 Cal/Wash |
| CD-478865D Ciba-Corning 664 Slope | 478865D Ciba-Corning 664 Slope |
| CD-473385D Bayer 800 Series 7.3/Co-ox Zero | 473385D Bayer 800 Series 7.3/Co-ox Zero |
| CD-473386D Bayer 800 Series 6.8 Buffer | 473386D Bayer 800 Series 6.8 Buffer |
| CD-473387D Bayer 800 Series Wash/Cal G/L Zero | 473387D Bayer 800 Series Wash/Cal G/L Zero |
| CD-570096D Bayer 800 Series Cal G/L | 570096D Bayer 800 Series Cal G/L |
- . The OEM products for Ciba-Corning Instruments (238, 248, 348, 664, & 200 Series) were originally released under the Ciba-Corning name. The company has under gone several owner and name changes: starting out as Corning Glass, Ciba-Corning, Chiron, and Iastly
1
Bayer. For the purposes of this 510(k) the OEM for theses products will be referred to as Ciba-Corning.
- The OEM products for Bayer Instrument (800 Series (aka RapidLab) were originally released . under the Chiron name. The company has under gone several owner and name changes: starting out as Corning Glass, Ciba-Corning, Chiron, and lastly Bayer. For the purposes of this 510(k) the OEM for theses products will be referred to as Bayer.
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 and rinse the sample path.
- Intended Use: .
- The reagents are intended for use on equivalent OEM Instruments. .
- 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.
- 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 Data
Precision data are collected from the analysis of three levels of control materials tested over a minimum of 7 days on each OEM analyzer. Analyzers are calibrated with Mission reagents and alternately with the OEM reagents for testing.
2
Precision Data Table - 238 Ciba-Corning pH/BG Analyzer
238 Instr
pH
| Mission | ||||||
|---|---|---|---|---|---|---|
| Level | N | Mean | Stdev | Min | Max | % CV |
| QC1 | 9 | 7.15 | 0.01 | 7.15 | 7.16 | 0.1% |
| QC2 | 9 | 7.41 | 0.01 | 7.40 | 7.44 | 0.2% |
| QC3 | 9 | 7.64 | 0.01 | 7.63 | 7.65 | 0.1% |
| of performer I it in continue | ||
|---|---|---|
| Instr | 238 | |
pO2
| Mission | ||||||
|---|---|---|---|---|---|---|
| Level | N | Mean | Stdev | Min | Max | % CV |
| QC1 | 9 | 63 | 1 | 62 | 64 | 1.2% |
| QC2 | 9 | 101 | 2 | 98 | 103 | 1.6% |
| QC3 | 9 | 158 | 6 | 151 | 169 | 3.7% |
238 Instr
pCO2
| Mission | ||||||
|---|---|---|---|---|---|---|
| Level | N | Mean | Stdev | Min | Max | % CV |
| QC1 | 9 | 81 | 2 | 77 | 83 | 2.7% |
| QC2 | 9 | 45 | 1 | 44 | 46 | 1.6% |
| QC3 | 9 | 18 | 0 | 18 | 19 | 2.4% |
Precision Data Table - 248 Ciba-Corning pH/BG Analyzer
Instr 248
pH
| Mission | ||||||
|---|---|---|---|---|---|---|
| Level | N | Mean | Stdev | Min | Max | % CV |
| QC1 | 10 | 7.156 | 0.003 | 7.151 | 7.160 | 0.0% |
| QC2 | 10 | 7.403 | 0.003 | 7.397 | 7.407 | 0.0% |
| QC3 | 10 | 7.630 | 0.005 | 7.622 | 7.639 | 0.1% |
Instr 248 pO2
| Mission | ||||||
|---|---|---|---|---|---|---|
| Level | N | Mean | Stdev | Min | Max | % CV |
| QC1 | 10 | 53.9 | 2.5 | 51.6 | 59.7 | 4.6% |
| QC2 | 10 | 94.9 | 1.1 | 93.0 | 96.9 | 1.1% |
| QC3 | 10 | 160.8 | 3.3 | 157.2 | 167.7 | 2.1% |
Instr 248 pCO2
| Level | N | Mean | Stdev | Min | Max | % CV |
|---|---|---|---|---|---|---|
| QC1 | 10 | 77.3 | 1.0 | 76.3 | 79.7 | 1.3% |
| QC2 | 10 | 47.0 | 0.4 | 46.6 | 47.8 | 0.8% |
| QC3 | 10 | 21.8 | 0.2 | 21.5 | 22.0 | 0.7% |
3
Precision Data Table - 248 Ciba-Corning pH/BG & Electrolyte Analyzer
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
IT THE FORT COLL A LANSING MANUFACTURES POR LAND
Instr | September 19, 2011
348 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| | |
Na
| Mission | |||||||
|---|---|---|---|---|---|---|---|
| Level | N | Mean | StdDev | Min | Max | %CV | |
| QC1 | 21 | 113 | 2.0 | 110 | 118 | 1.8% | |
| QC2 | 21 | 139 | 2.7 | 135 | 147 | 1.9% | |
| QC3 | 20 | 162 | 2.4 | 158 | 169 | 1.5% |
K
| Instr | 348 |
|---|---|
| ------- | ----- |
| Level | Mission | |||||
|---|---|---|---|---|---|---|
| N | Mean | StdDev | Min | Max | %CV | |
| QC1 | 21 | 2.10 | 0.02 | 2.06 | 2.13 | 0.8% |
| QC2 | 21 | 4.38 | 0.06 | 4.16 | 4.43 | 1.3% |
| QC3 | 21 | 6.88 | 0.08 | 6.74 | 7.01 | 1.2% |
Ca
| Level | Mission | |||||
|---|---|---|---|---|---|---|
| N | Mean | StdDev | Min | Max | %CV | |
| QC1 | 21 | 2.06 | 0.08 | 1.75 | 2.13 | 4.1% |
| QC2 | 21 | 1.16 | 0.06 | 0.94 | 1.25 | 5.4% |
| QC3 | 21 | 0.58 | 0.06 | 0.44 | 0.65 | 10.4% |
| ALL PROPERTY OF CO | COLLEGE |
|---|---|
pH
| Mission | ||||||
|---|---|---|---|---|---|---|
| Level | N | Mean | Stdev | Min | Max | %CV |
| QC1 | 10 | 7.166 | 0.006 | 7.154 | 7.177 | 0.1% |
| QC2 | 10 | 7.442 | 0.019 | 7.418 | 7.476 | 0.3% |
| QC3 | 10 | 7.669 | 0.027 | 7.634 | 7.717 | 0.4% |
4
Precision Data Table - 664 Ciba-Corning Analyzer
| Instr | 664 |
|---|---|
| ------- | ----- |
Na
| Mission | |||||||
|---|---|---|---|---|---|---|---|
| Level | N | MEAN | stdev | Min | Max | % CV | |
| QC1 | 16 | 112.0 | 1.4 | 110.0 | 114.9 | 1.3% | |
| QC2 | 16 | 137.6 | 0.9 | 136.8 | 139.4 | 0.6% | |
| QC3 | 16 | 162.3 | 1.0 | 161.1 | 164.4 | 0.6% |
| The former of the state of the comments of the comments of the county of the county of | s C |
|---|---|
| Instr | 1 |
K
| Mission | ||||||
|---|---|---|---|---|---|---|
| Level | N | Mean | Stdev | Min | Max | % CV |
| QC1 | 16 | 1.98 | 0.03 | 1.95 | 2.04 | 1.3% |
| QC2 | 16 | 4.38 | 0.04 | 4.34 | 4.46 | 0.9% |
| QC3 | 16 | 6.99 | 0.07 | 6.92 | 7.14 | 1.0% |
| Instr | ନିର୍ବିଧ
00
1 |
| ------- | -------------------- |
|---|
Cl
| Mission | ||||||
|---|---|---|---|---|---|---|
| Level | N | Mean | Stdev | Min | Max | % CV |
| QC1 | 16 | 83 | 4.6 | 77 | 99 | 5.6% |
| QC2 | 16 | 99 | 7.9 | 91 | 127 | 8.0% |
| QC3 | 16 | 122 | 9.4 | 88 | 127 | 7.7% |
Instr 664 tCO2
| Mission | ||||||
|---|---|---|---|---|---|---|
| Level | N | Mean | Stdev | Min | Max | % CV |
| QC1 | 16 | 28.8 | 1.3 | 26.3 | 31.1 | 4.6% |
| QC2 | 16 | 30.4 | 1.3 | 28.4 | 32.3 | 4.2% |
| QC3 | 16 | 23.3 | 0.8 | 21.9 | 24.8 | 3.6% |
5
Precision Data Table - 288 Ciba-Corning pH/BG & Electrolyte Analyzer
| AND | ||
|---|---|---|
| str | 288 |
Na
| Level | Mission | |||||
|---|---|---|---|---|---|---|
| N | Mean | Stdev | Min | Max | % CV | |
| QC1 | 19 | 108.0 | 0.8 | 107.0 | 110.0 | 0.7% |
| QC2 | 19 | 134.3 | 0.7 | 132.7 | 135.7 | 0.5% |
| QC3 | 19 | 159.2 | 1.0 | 157.3 | 160.7 | 0.6% |
| Instr | 288 |
|---|---|
| ------- | ----- |
K
| Mission | ||||||
|---|---|---|---|---|---|---|
| Level | N | Mean | Stdev | Min | Max | % CV |
| QC1 | 19 | 1.66 | 0.02 | 1.63 | 1.69 | 1.1% |
| QC2 | 19 | 4.25 | 0.02 | 4.22 | 4.29 | 0.6% |
| QC3 | 19 | 7.07 | 0.04 | 7.02 | 7.14 | 0.6% |
Instr 288 Ca
| Mission | ||||||
|---|---|---|---|---|---|---|
| Level | N | Mean | Stdev | Min | Max | % CV |
| QC1 | 19 | 2.13 | 0.03 | 2.03 | 2.18 | 1.6% |
| QC2 | 19 | 1.12 | 0.01 | 1.09 | 1.14 | 1.0% |
| QC3 | 18 | 0.48 | 0.01 | 0.45 | 0.51 | 2.8% |
Instr 288 pH
| Mission | |||||||
|---|---|---|---|---|---|---|---|
| Level | N | Mean | Stdev | Min | Max | % CV | |
| QC1 | 25 | 7.182 | 0.012 | 7.166 | 7.210 | 0.2% | |
| QC2 | 25 | 7.426 | 0.012 | 7.403 | 7.455 | 0.2% | |
| QC3 | 25 | 7.651 | 0.005 | 7.645 | 7.661 | 0.1% |
Correlation with OEM Reagents
Correlation data for electrolytes on the 348 were obtained from human serum samples for Na, K, Cl, Ca. Samples are spiked with Human Serum Albumin to yield varying concentrations of each of the measuring analytes. The serum samples were measured on the 348 analyzer calibrated with Mission reanents for 1 run and 1 comparison run with OEM reagents each test day
Correlation for pH were obtained by comparing 3 levels of QC.
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
Correlations demonstrated slopes of 1 and R 's of 0.99, which support a claim of substantial equivalence. Graphs of Correlation are in Attachment Section.
6
Regression Analysis of Mission vs OEM; Human Serum Results
| Na | |||||
|---|---|---|---|---|---|
| N | Slope | Intercept | R2 | Range | |
| 348 | 44 | 1.02 | -0.96 | 0.99 | 103 - 185 |
| 288 | 19 | 0.95 | 8.88 | 1.00 | 103 - 171 |
| 664 | 25 | 0.95 | 6.57 | 1.00 | 93 - 173 |
Y = mX + b where Y = OEM results, X = Mission results, m = Slope, b = Intercept
| N | Slope | Intercept | R2 | Range | |
|---|---|---|---|---|---|
| 348 | 49 | 1.00 | 0.05 | 1.00 | 2.39 - 5.87 |
| 288 | 44 | 1.04 | -0.06 | 1.00 | 1.54 - 6.59 |
| 664 | 44 | 1.02 | -0.04 | 1.00 | 1.82 - 6.56 |
..
| Ca | |||||
|---|---|---|---|---|---|
| N | Slope | Intercept | R2 | Range | |
| 348 | 35 | 0.96 | 0.07 | 0.99 | 0.94 - 2.11 |
| 288 | 44 | 1.00 | -0.05 | 0.99 | 0.94 - 2.48 |
| | | 1 | | .
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|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|----------------------------------|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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1 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 1
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- | -
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----- |
Regression Analysis of Mission vs OEM; QC Results
Y = mX + b where Y = OEM results, X = Mssion results, m = Slope, b = Intercept
| pH | |||||
|---|---|---|---|---|---|
| N | N | Slope | Intercept | R2 | Range |
| 238 | 30 | 1.00 | 0.03 | 1.00 | 7.15 - 7.65 |
| 248 | 30 | 1.01 | -0.06 | 1.00 | 7.151 - 7.639 |
| 348 | 30 | 1.00 | -0.01 | 0.99 | 7.151 - 7.717 |
| 288 | 21 | 0.98 | 0.17 | 1.00 | 7.163 - 7.661 |
7
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms Linda Stundtner OA/RA Manager Diamond Diagnostics Inc. Mission Diagnostics 333 Fiske Street Holliston, MA 01746
APR 2 9 2002
Re: K020894
Trade/Device Name: Mission Diagnostic Reagents for pH/BG &/or Electrolyte Analyzers Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II
Product Code: JIT Dated: March 18, 2002 Received: March 19, 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.
8
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 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device. please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".
Sincerely vours.
Steven Butman
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
9
510(k( Number
020894
Device Name: Mission Diagnostic Reagents for pH/BG &/or Electrolyte Analyzers
Indication For Use:
The products encompassed by this request are intended for in-vitro diagnostics use and are intended for r ne products chooling and flushing the sample flow path of the equivalent OEM Analyzers.
| Mission Product PN | OEM Instrument(s) Used on |
|---|---|
| AV-BP0136D Type 1 Buffer 7.383 | AVL 99X and Compact Analyzers |
| AV-BP0137D Type 2 Buffer 6.841 | AVL 99X and Compact Analyzers |
| CD-473691AD Cal-Pak for Ciba-Corning 238 | Ciba-Corning 238 pH/BG Analyzer |
| CD-473496AD Cal-Pak for Ciba-Corning 248 | Ciba-Corning 248 pH/BG Analyzer |
| CD-104227AD Cal-Pak for Ciba-Corning 348 | Ciba-Corning 348 pH/BG & Electrolyte Analyzer |
| CD-478855D Ciba-Corning 200 Series 7.3 Buffer | Ciba-Corning 200Series pH/BG Analyzer |
| CD-478856D Ciba-Corning 200 Series 6.8 Buffer | Ciba-Corning 200 Series pH/BG Analyzer |
| CD-478864D Ciba-Corning 664 Cal/Wash | Ciba-Corning 664 Analyzer |
| CD-478865D Ciba-Corning 664 Slope | Ciba-Corning 664 Analyzer |
| CD-473385D Bayer 800 Series 7.3/Co-ox Zero | Bayer 800Series Analyzers |
| CD-473386D Bayer 800 Series 6.8 Buffer | Bayer 800Series Analyzers |
| CD-473387D Bayer 800 Series Wash/Cal G/L Zero | Bayer 800 Series Analyzers |
| CD-570096D Bayer 800 Series Cal G/L | Bayer 800Series Analyzers |
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)
T. Cox
(Division Sign-Off)
510(k) Number
Prescription Use X
(per 21 CFR 801.109)
(Optional format 3-10-98)