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

AI/ML Overview

The provided text describes performance characteristics for various calibrating materials. The acceptance criteria are implicitly defined by establishing "substantial equivalence" of the Mission Diagnostics calibrators to OEM calibrating materials. The studies aim to demonstrate that the Mission Diagnostics devices perform "equally" to the predicate OEM devices.

Here's an analysis of the provided information for the devices where detailed performance data is given:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criterion for all studies is that the Mission Diagnostics calibrator performs "equally" to the OEM calibrator. This is demonstrated through comparative studies, where the performance of the Mission device, when used to calibrate an instrument, results in QC and sample recoveries that correlate strongly with, and are comparable to, the recoveries obtained when the OEM device is used for calibration. This "equally" is quantified by high correlation coefficients ($r^2$) and low standard errors of the estimate (S(y.x)) in linear regression analysis, alongside comparable %CV values for precision.

Let's focus on three specific devices for which detailed performance data is provided: CD-105670D (Hct Slope), CD-471818D (634 Ca/pH Slope Standard), and CD-473692D (pH Blood Gas Slope).

Device/Analyte	Acceptance Criteria (Implicit: Performance "equally" to OEM, high correlation, low S(y.x))	Reported Device Performance (Mission vs. OEM)	Conclusion on Meeting Acceptance Criteria
CD-105670D (Hct Slope)	High $r^2$ and low S(y.x) between Mission and OEM calibrated results. Similar %CV for QC samples.	Regression: Mission = 0.999 * Corning - 0.818, Range = 26 & 48 %Hct, $r^2$ = 0.997, df = 95, n = 96, S(y.x) = 0.58 %Hct. QC Precision (Mission): QC-A: 2.2% CV; QC-B: 1.6% CV. QC Precision (OEM): QC-A: 1.0% CV; QC-B: 1.2% CV.	Met. Very high correlation ($r^2$=0.997) and minimal difference in %CVs.
CD-471818D (634 Ca/pH Slope Standard)	High $r^2$ and low S(y.x) between Mission and OEM calibrated results for both serum samples and QC samples. Similar %CV for QC samples.	Serum Sample Regression: Mission = 1.018 * Corning - 0.019, Range = 0.37 to 4.57 mmol/L, $r^2$ = 0.998, df = 68, n = 69, S(y.x) = 0.05 mmol/L. QC Sample Regression (Ca): Mission = 1.028 * Corning - 0.031, Range = 0.55 - 2.18, $r^2$ = 0.998, df = 32, n = 33, S(y.x) = 0.02 mmol/L Ca. QC Sample Regression (pH): Mission = 1.045 * Corning - 0.36, Range = 7.05 - 7.62, $r^2$ = 0.937, df = 32, n = 33, S(y.x) = 0.05. QC Precision (Mission Hct): pH: 0.18-0.62% CV; Ca: 0.62-1.50% CV. QC Precision (OEM Hct): pH: 0.21-0.67% CV; Ca: 0.84-1.90% CV.	Met. Very high correlation for Ca ($r^2$=0.998) and strong correlation for pH ($r^2$=0.937). %CVs are comparable.
CD-473692D (pH Blood Gas Slope)	High $r^2$ and low S(y.x) between Mission and OEM calibrated results for QCs. Similar %CV for QC samples.	QC Regression (pH): Mission = 1.053 * Corning - 0.392, Range = 7.02 to 7.60, $r^2$ = 0.987, df = 112, n = 113, S(y.x) = 0.02. QC Regression (pCO2): (No data provided for pCO2 regression statistics in the excerpt.) QC Regression (pO2): Mission = 1.001 * Corning + 0.661, Range = 71 to 142 mm Hg pO2, $r^2$ = 0.972, df = 112, n = 113, S(y.x) = 4.19 mm Hg. QC Precision (Mission): pH: 0.02-0.30% CV; pCO2: 2.1-2.6% CV; pO2: 1.6-3.7% CV. QC Precision (OEM): pH: 0.23-0.26% CV; pCO2: 2.4-3.0% CV; pO2: 1.8-3.8% CV.	Met. High correlation for pH ($r^2$=0.987) and pO2 ($r^2$=0.972). %CVs are very comparable.

2. Sample Sizes Used for the Test Set and the Data Provenance

The studies are designed as comparative performance evaluations between the Mission Diagnostics calibrators and the OEM calibrators.

CD-105670D (Hct Slope):
- Test Set Sample Size: n=96 individual QC observations for regression analysis (derived from 7 days, 2 runs each for Mission and OEM, with 2 QC samples measured in duplicate for each run, so 7 days * 2 runs/day * 2 QC samples * 2 duplicates = 56 for Mission and same for OEM, which might imply n=112 total measurements, or 96 for the regression points between Mission and OEM).
- Data Provenance: Not explicitly stated, but the context of an in vitro diagnostic device for clinical analyzers implies laboratory testing, likely prospective. Country of origin not specified.
CD-471818D (634 Ca/pH Slope Standard):
- Test Set Sample Size:
  - Serum samples: n=69 for regression analysis.
  - QC samples (Ca): n=33 for regression analysis.
  - QC samples (pH): n=33 for regression analysis.
  - QC precision studies: 12 replicates for each of 3 QC levels for both Mission and OEM for both Ca and pH (total 1232*2 = 144 measurements for QCs alone).
- Data Provenance: Not explicitly stated, but implies laboratory testing using spiked/diluted serum samples and QC materials. Likely prospective. Country of origin not specified.
CD-473606D (654 Lithium Slope Solution 2.50 mmol/L):
- Test Set Sample Size:
  - Serum samples: n=28 for regression analysis.
  - QC precision studies: 20 replicates for each of 3 QC levels for both Mission and OEM for Na, K, and Li (total 2032*3 = 360 measurements for QCs alone).
- Data Provenance: Not explicitly stated, but implies laboratory testing using spiked/diluted serum samples and QC materials. Likely prospective. Country of origin not specified.
CD-473692D (pH Blood Gas Slope):
- Test Set Sample Size:
  - QC samples: n=113 for pH regression analysis, n=113 for pO2 regression analysis.
  - Precision studies: N varies by analyte and level (e.g., pH Level 1 has 36 observations for Mission, 37 for OEM). Total observations for QC precision for pH, pCO2, pO2 across 3 levels over 5 days, 2 runs/day with 4 replicates per run (implied n=8 per QC sample per day for each calibrator) = (36+38+40) + (37+40+39) = 230 for pH. Similar counts for pCO2 and pO2.
- Data Provenance: Not explicitly stated, but implies laboratory testing using QC materials. Likely prospective. Country of origin not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. These studies do not involve human expert interpretation of results to establish ground truth. The "ground truth" (or reference values) for quality control materials and serum samples in these types of in vitro diagnostic studies are typically established by certified reference methods, inter-laboratory comparisons, or assigned values by the manufacturer of the QC materials, under a strict quality management system in a laboratory setting. The predicate device (OEM calibrator) acts as the comparative standard.

4. Adjudication Method for the Test Set

Not applicable. There is no human adjudication process described, as the evaluation is based on quantitative analytical results comparing the performance of two calibrators.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. These are studies for in vitro diagnostic calibrators, not AI-assisted human reader studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, these are standalone performance studies of the calibrator materials in conjunction with the specified automated analyzers. The calibrators themselves are not an "algorithm" in the typical sense, but rather a chemical reagent. The performance is determined by how well the analytical system (instrument + calibrator) performs compared to the system calibrated with the OEM device. The results (e.g., QC recoveries, analyte concentrations) are measured directly by the instrument.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth or reference standard is the performance achieved when the respective analyzer is calibrated using the OEM calibrator. The study's objective is to show that the Mission Diagnostics calibrator produces equivalent results to the OEM calibrator, implying that the OEM calibrator's performance represents the acceptable "truth" or standard. Additionally, the QC samples used have established target values (though not explicitly stated as "ground truth" in the text, it is implied as a reference for assessing accuracy and precision). For serum samples, the "ground truth" is typically the reference values established through the OEM calibration.

8. The Sample Size for the Training Set

Not applicable. These are not machine learning (AI) models that require a training set. The "training" in this context refers to the calibration of the analyzer, which uses the calibrator material itself, not a separate data set.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for an AI model. The calibrators "train" (calibrate) the instrument by providing known reference points for the instrument to adjust its measurement scale. The values of these calibrators are established by the manufacturer, Mission Diagnostics, and are designed to be equivalent to the OEM's calibrators.

Summary

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510(k) Summary
for Mission Diagnostic Reagents
on pH/Blood Gas &/or Electrolyte Analyzers

1. Submitter's Name & Address	Mission Diagnostics331 Fiske StHolliston MA 01746FAX: 508-429-0452
Contact Person:	Linda StundtnerQA/RA Manager508-429-0450

Establishment Registration Number:	3003656721
Date of Preparation:	Dec. 29, 2003

Identification of the Device:

Proprietary/Trade name:	Calibrating Material, Calibrating standards
Common or usual name	Calibrators for ISE and/or pH/Blood Gas automated systems
Classification name:	Calibrator, secondary
Device Classification	II

21 CFR § 862.1150

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:

Panel:

Regulation Number:

Product Code:

4 2004
Mission claims substantial equivalence to the OEM Calibrating Materials listed below: .

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

#	Mission Diagnostics		OEM* Equivalent			Cleared Date	PN	Description	Intended Use
			Predicate Device				AV-BP1579D	BG Calibrator	Provide a second calibration point for AVL Compact 1pH/Blood Gas Analyzer.
1	AV-BP1579D	BG Calibrator	BP1579	BG Calibrator	K943570	08-24-1994	CD-105670D	Hct Slope	Provide a second calibration point for the Hct sensor onthe 348 Analyzer.
2	CD-105670D	Hct Slope	105670	Hct Slope	K962021	06-24-1996	CD-471818D	634 Ca/pH Slope Standard	To provide a second calibration point for the Ca & pHelectrodes on the 634 Ca/pH Analyzer.
3	CD-471818D	634 Ca/pH SlopeStandard	471818	634 Slope Standard$2.50^{Ca}/6.84^{pH}$	K844188	11-23-1988	CD-473606D	654 Lithium Slope Solution 2.50 mmol/L	To provide a second calibration point for the Lithiumelectrode on the 654 Na/K/Li Analyzer.
4	CD-473606D	654 Lithium SlopeSolution 2.50 mmol/L	473606	654 Lithium SlopeSolution 2.50 mmol/L	K884769	01-17-1989	CD-473692D	pH Blood Gas Slope	To provide a second calibration point for pH, pCO2, andpO2 on 238 pH/Blood Gas Analyzer.
5	CD-473692D	pH Blood Gas Slope	473692	pH Blood Gas Slope	K904188	09-27-1990	RD-944015D	Calibrating Solution 1, Btl# 9	To provide a calibration point for the Na+, K+, Ca++, Cl-,pH and glucose, lactate electrodes on Radiometer 605,615, 625, EML 100 & 105 Analyzers.
6	RD-944015D	Calibrating Solution 1,Bt # 9	944015	Calibrating Solution 1,Btl# 9	K954612	11-09-1995	RD-944030D	Calibrating Solution 1, Btl# 3	To provide a calibration point for the Na+, K+, Ca++, Cl-,pH and glucose, lactate electrodes on Radiometer 605,615, 625, EML 100 & 105 Analyzers.
7	RD-944030D	Calibrating Solution 1,Bt # 3	944030	Calibrating Solution 1,Btl# 3	K973367	10-06-1997	RD-944031D	Calibrating Solution 2, Btl# 4	To provide a second calibration point for the Na+, K+,Ca++, Cl-, and pH electrodes on Radiometer 555Analyzer.
8	RD-944031D	Calibrating Solution 2,Bt # 4	944031	Calibrating Solution 2,Btl# 4			BK-465908D	Calibrator 1	Used in conjunction with Calibrator 2 and 3 to calibrateNa, K, Cl, Ca, TCO2, Glucose, BUN, & Creatinine onBeckman Synchron CX Delta, CX®CE, and CX9 ALXSystems.
9	BK-465908D	Calibrator 1	465908	Calibrator 1			BK-465909D	Calibrator 2	Used in conjunction with Calibrator 1 and 3 to calibrateNa, K, Cl, Ca, TCO2, Glucose, BUN, & Creatinine onBeckman Synchron CX Delta, CX®CE, and CX9 ALXSystems.
10	BK-465909D	Calibrator 2	465909	Calibrator 2	K942676	11-02-1994	BK-465910D	Calibrator 3	Used in conjunction with Calibrator 1 and 2 to calibrateNa, K, Cl, Ca, TCO2, Glucose, BUN, & Creatinine onBeckman Synchron CX Delta, CX®CE, and CX9 ALXSystems.
11	BK-465910D	Calibrator 3	465910	Calibrator 3			BK-443360D	Calibration Standard 1	Used in conjunction with Calibration Standard 2 tocalibrate Na, K, Cl, Ca, TCO2, Glucose, BUN, &Creatinine on Beckman Synchron CX3 and CX5Systems.
12	BK-443360D	Calibration Standard 1	443360	Calibration Standard 1	K864236	12-31-1986	BK-443365D	Calibration Standard 2	Used in conjunction with Calibration Standard 1 tocalibrate Na, K, Cl, Ca, TCO2, Glucose, BUN, &Creatinine on Beckman Synchron CX3 and CX5Systems.
13	BK-443365D	Calibration Standard 2	443365	Calibration Standard 2			BM-620427D	ISE Standard High	To provide a calibration point for Na+, K+ and Cl-electrodes on the ISE module of Hitachi 7xx, 911, 912and 917 Analyzers.
14	BM-620427D	ISE Standard High	620427	ISE Standard High	K811194	05-27-1981	BM-620428D	ISE Standard Low	To provide a calibration point for Na+, K+ and Cl-electrodes on the ISE module of Hitachi 7xx, 911, 912and 917 Analyzers.
15	BM-620428D	ISE Standard Low	624028	ISE Standard Low

OEM = Original Equipment Manufacturer

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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: .

For each Calibrator included in this submission, the calibrator is intended for use on equivalent . OEM Instruments, i.e. predicate device and are necessary for the continued operation and use of the instruments.
For each Calibrator included in this submission, 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.

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5. Performance Characteristics:

See table below for Summary.

PN	Description	Performance Data collected:	Results:
CD-105670D	Hct Slope	Precision and correlation data are collected per: SOP23-01-02 Performance Study Protocol for 510(k) Submission with the following modifications: Testing was conducted over 7 days, 2 runs each, Mission and OEM, per day. The 348 Hct sensor was sloped with the OEM Hct slope and Hct QC samples were measured in duplicate. The Hct Sensor was calibrated and Hct QC samples were measured in duplicate – this equaled 1 run, n= 4 per QC sample. 2 runs were completed each day, n=8 per QC sample. The 348 Hct sensor was sloped with the Mission Hct slope and Hct QC samples were measured in duplicate. The Hct Sensor was calibrated and Hct QC samples were measured in duplicate - this equaled 1 run, n= 4 per QC sample. 2 runs were completed each day, n=8 per QC sample. Hct Slope is an ampuled product used to provide a slope point for the Hct sensor. Other required reagents to run the 348 instrument remained constant throughout testing.	Summary of QC Recovery and Precision for 348 Hct Slope CD-105670DSummary of QC Data Analyte Level N Mean Sd Min Max %CV %Hct QC - A 56 26 0.6 24 27 2.2 QC - B 56 48 0.8 45 49 1.6 OEM %Hct QC - A 48 27 0.3 26 27 1.0 QC - B 48 49 0.6 48 50 1.2 Recoveries of individual QC observations when 348 Hct sensor sloped with Mission Hct Slope vs OEM Hct Slope were compared by least squares regression. The following statistics were obtained:Mission = 0.999 x Corning - 0.818Range = 26 & 48 %Hct; $r^2$ = 0.997; df = 95; n = 96; S(y.x) = 0.58 %HctMission Hct Slope performed equally to the OEM Hct Slope.

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PN	Description	Performance Data collected:	Results:
CD-471818D	634 Ca/pH Slope Standard	Precision and correlation data are collected per:SOP23-01-02 Performance Study Protocol for 510(k) Submission with the following modifications:Serum samples were spiked or diluted to yield Ca samples ranging from 0.37-4.57 mmol/L. 5 replicates of a serum sample and 1 replicate of each of 3 levels of QC were tested in a calibrated run. Samples were tested over a three-day period. All samples and QC's were tested in calibrated runs where Mission 634 Ca/pH Slope was used for the slope point and in calibrated runs where the OEM 634 Slope Standard was used for the slope point. The 634 Ca/pH Slope Standard is an ampuled product used to provide a slope point for Ca & pH on the 634. Other required reagents to run the 634 instrument remained constant throughout testing.	Table of QC Data for 634 Ca/pH Slope CD-471818D & OEMSummary QC Data for Ca and pH - with Mission 634 Slope Analyte Level N Mean Sd Min Max %CV pH 1 12 7.11 0.04 7.05 7.18 0.62 2 12 7.41 0.02 7.37 7.45 0.33 3 12 7.60 0.01 7.58 7.62 0.18 Ca 1 12 2.13 0.03 2.08 2.15 1.32 2 12 1.07 0.01 1.06 1.08 0.62 3 12 0.56 0.01 0.55 0.56 1.50 Summary QC Data for Ca and pH - with Corning 634 Slope Analyte Level N Mean Sd Min Max %CV pH 1 12 7.18 0.05 7.08 7.22 0.67 2 12 7.41 0.04 7.36 7.50 0.54 3 12 7.58 0.02 7.57 7.63 0.21 Ca 1 12 2.10 0.03 2.08 2.15 1.24 2 12 1.08 0.01 1.06 1.09 0.84 3 12 0.57 0.01 0.55 0.59 1.90 Recoveries of individual serum observations were compared by least squares regression.The following statistics were obtained:Mission = 1.018 x Corning - 0.019Range = 0.37 to 4.57 mmol/L; r² = 0.998; df = 68; n = 69; S(y.x) = 0.05 mmol/LRecoveries of individual QC observations when 634 calibrated with Mission 634 Ca/pH Slope Standard vs OEM 634 Slope Standard were compared by least squares regression.The following statistics were obtained:For CaMission = 1.028 x Corning - 0.031Range = 0.55 - 2.18; r² = 0.998; df = 32 n = 33; S(y.x) = 0.02 mmol/L CaFor pHMission = 1.045 x Corning - 0.36Range = 7.05 - 7.62; r² = 0.937; df = 32; n = 33; S(y.x) = 0.05Mission 634 Ca/pH Slope performed equally to the OEM 634 Slope Standard.

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PN	Description	Performance Data collected:	Results:
CD-473606D	654 LithiumSlope Solution	Precision and correlation data are collected per:	Table of QC Data for 654 Li Slope CD-473606D & OEMSummary of QC Data with Mission 654 Li Slope Standard Analyte Level N Mean Sd Min Max %CV Na 1 20 119 0.6 118 120 0.5 2 20 141 0.6 140 142 0.4 3 20 165 0.7 164 167 0.4 K 1 20 2.09 0.03 2.00 2.14 1.59 2 20 4.26 0.05 4.10 4.34 1.09 3 20 6.71 0.09 6.40 6.83 1.36 Li 1 20 0.33 0.02 0.29 0.38 6.8 2 20 1.14 0.05 1.06 1.22 4.3 3 20 2.17 0.09 2.01 2.28 4.0 Summary of QC Data with OEM 654 Li Slope Standard Analyte Level N Mean Sd Min Max %CV Na 1 20 119 0.6 118 120 0.5 2 20 141 0.6 140 142 0.4 3 20 166 0.5 165 166 0.3 K 1 20 2.10 0.02 2.05 2.13 1.04 2 20 4.26 0.03 4.20 4.32 0.76 3 20 6.72 0.08 6.59 6.90 1.17 Li 1 20 0.38 0.02 0.34 0.42 5.2 2 20 1.14 0.04 1.09 1.19 3.1 3 20 2.10 0.06 2.02 2.18 2.7 Recoveries of individual serum observations were compared by least squares regression.Scatter plot of individual observations are below. The following statistics were obtained:Mission = 1.050 x Corning - 0.075Range = 0.28 to 2.95 mmol/L; $r^2$ = 0.998; df = 27; n = 28; S(y.x) = 0.04 mmol/L LiMission 654 Li Slope Standard performed equally to the OEM 654 Li Slope Standard
		2.50 mmol/L		SOP23-01-02 Performance Study Protocol for 510(k) Submission with the followingmodifications: Serum samples were spiked or diluted to yield Li samples ranging from 0.28 - 2.95 mmol/L. 5 replicates of a serum sample and 1 replicate of each of 3 levels of QC were tested in a calibrated run. Samples were tested over a four-day period. All samples and QC's were tested in calibrated runs where Mission 654 Li Slope was used for the slope point and in calibrated runs where the OEM 654 Li Slope Standard was used for the slope point. The 654 Li Slope Standard is an ampuled product used to provide a slope point for Li on the 654. Other required reagents to run the 654 instrument remained constant throughout testing.

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PN	Description	Performance Data collected:	Results:
CD-473692D	pH Blood Gas Slope	Precision and correlation data are collected per:SOP23-01-02 Performance Study Protocol for 510(k) Submission with the following modifications:• Testing was conducted over 5 days, 2 runs each, Mission and OEM, per day.• The 238 was calibrated then sloped with Mission pH/Blood Gas Slope. 3 levels of QC were tested: QC 1, QC2, QC3, QC3, QC2, QC1 – a new ampule tested for each sample. The 238 was calibrated and 3 levels of QC tested as before. This equaled 1 run, n= 4 for each QC level. 2 runs were completed each day, n=8 per OC sample.• The 238 was calibrated and then sloped with the OEM pH/Blood Gas Slope. 3 levels of QC were tested: QC 1, QC2, QC3, QC3, QC2, QC1 - a new ampule tested for each sample. The 238 was calibrated and 3 levels of QC tested as before. This equaled 1 run, n= 4 for each QC level. 2 runs were completed each day, n=8 per QC sample.The pH/Blood Gas Slope is an ampuled product used to provide a slope point for pH, pCO2, pO2 on the 238. Other required reagents to run the 238 instrument remained constant throughout testing.	Table of QC Data for 238 Slope CD-473692D vs OEMSummary of QC Data – with Mission 238 Slope
			Analyte	Level	N	Mean	Sd	Min	Max	%CV
			pH	1	36	7.05	0.01	7.02	7.08	0.02
				2	38	7.33	0.02	7.30	7.38	0.25
				3	40	7.55	0.02	7.50	7.60	0.30
			pCO2	1	36	95	2.1	92	99	2.2
				2	38	47	1.5	44	50	2.1
				3	40	22	0.6	21	23	2.6
			pO2	1	36	73	1.2	71	76	1.6
				2	38	113	4.1	106	121	3.7
				3	40	133	3.6	128	142	2.7
			Summary of QC Data – with OEM 238 Slope
			Analyte	Level	N	Mean	Sd	Min	Max	%CV
			pH	1	37	7.06	0.02	7.02	7.11	0.24
				2	40	7.33	0.02	7.29	7.36	0.23
				3	39	7.54	0.02	7.49	7.57	0.26
			pCO2	1	37	90	2.1	87	94	2.4
				2	40	46	1.3	44	49	2.8
				3	39	22	0.7	21	23	3.0
			pO2	1	37	73	1.3	70	75	1.8
				2	40	113	4.3	103	122	3.8
				3	39	132	3.6	132	143	2.8
			Recoveries for pH of individual QC observations were compared by least squares regression. The following statistics were obtained:Mission = 1.053 x Corning - 0.392Range = 7.02 to 7.60; r = 0.987; df = 112; n = 113; S(y.x) = 0.02Recoveries for pH of individual QC observations were compared by least squares regression. The following statistics were obtained:Mission = 1.053 x Corning - 0.392Range = 7.02 to 7.60; r = 0.987: df = 112; n = 113; S(y.x) = 0.02Recoveries for pO2 of individual QC observations were compared by least squares regression. The following statistics were obtained:Mission = 1.001 x Corning + 0.661Range = 71 to 142 mm Hg pO2; r = 0.972; df = 112; n = 113; S(y.x) = 4.19 mm Hg

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." arranged around the top half of the circle. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR - 4 2004

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

K033060 Re:

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: December 29, 2003 Received: January 20, 2004

Dear Ms. Stundtner:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have a vote 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 for use surfar to May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of Print of Print of the provisions of 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 r ou may, ato s 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 1 tease to havinou and i bronination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I 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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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.

Jean M. Cooper, MS, DVM.

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k( Number ________________________________________________________________________________________________________________________________________________________________

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 use . in calibrating equivalent OEM Analyzers.

PN	Description	Intended Use
AV-BP1579D	BG Calibrator	Provide a second calibration point for AVL Compact 1 pH/Blood Gas Analyzer.
CD-105670D	Hct Slope	Provide a second calibration point for the Hct sensor on the 348 Analyzer.
CD-471818D	634 Ca/pH SlopeStandard	To provide a second calibration point for the Ca & pH electrodes on the 634 Ca/pHAnalyzer.
CD-473606D	654 Lithium SlopeSolution 2.50 mmol/L	To provide a second calibration point for the Lithium electrode on the 654 Na/K/LiAnalyzer.
CD-473692D	pH Blood Gas Slope	To provide a second calibration point for pH, pCO2, and pO2 on 238 pH/Blood GasAnalyzer.
RD-944015D	Calibrating Solution 1,Btl# 9	To provide a calibration point for the Na+, K+, Ca++, Cl-, pH and glucose, lactateelectrodes on Radiometer 605, 615, 625, EML 100 & 105 Analyzers.
RD-944030D	Calibrating Solution 1,Btl# 3	To provide a calibration point for the Na+, K+, Ca++, Cl-, pH and glucose, lactateelectrodes on Radiometer 605, 615, 625, EML 100 & 105 Analyzers.
RD-944031D	Calibrating Solution 2,Btl# 4	To provide a second calibration point for the Na+, K+, Ca++, Cl-, and pH electrodeson 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 Beckman Synchron CX Delta, CX®CE, and CX9ALX Systems.
BK-465909D	Calibrator 2	Used in conjunction with Calibrator 1 and 3 to calibrate Na, K, Cl, Ca, TCO2,Glucose, BUN, & Creatinine on Beckman Synchron CX Delta, CX®CE, and CX9ALX Systems.
BK-465910D	Calibrator 3	Used in conjunction with Calibrator 1 and 2 to calibrate Na, K, Cl, Ca, TCO2,Glucose, BUN, & Creatinine on Beckman Synchron CX Delta, CX®CE, and CX9ALX Systems.
BK-443360D	Calibration Standard 1	Used in conjunction with Calibration Standard 2 to calibrate Na, K, Cl, Ca, TCO2,Glucose, BUN, & Creatinine on Beckman Synchron 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 Beckman Synchron CX3 and CX5 Systems.
BM-620427D	ISE Standard High	To provide a calibration point for Na+, K+ and Cl- electrodes on the ISE module ofHitachi 7xx, 911, 912 and 917 Analyzers.
BM-620428D	ISE Standard Low	To provide a calibration point for Na+, K+ and Cl- electrodes on the ISE module ofHitachi 7xx, 911, 912 and 917 Analyzers.

Mission reagents are intended to serve as direct replacements to the predicate device 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 C Benson
Division Sign Off

tional format 3-10-98)

X Prescription Use

510(k) K033060

Regulation Number and Section

§ 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.