The three products encompassed by this request are intended for in-vitro diagnostics use. Mission Electrolyte Reference Reagent provides reference points for Na, K, CI, Ca (on Delta's only) and TCO2. When used in conjunction with CO2 Acid Reagent, CO2 Alkaline Buffer and Electrolyte Buffer, the ISE Electrolyte Reference is used for the calibration of the ISE electrodes; sodium, potassium chloride and calcium (on Delta's only) and CO2. The CO2 Acid reagent is used to release CO2 from samples. The CO2 Alkaline in used to provide a constant CO2 concentration as reference for the CO2 electrode. Mission reagents are intended to serve as direct replacements to the predicate devices manufactured by the OEM. The products encompassed are to be handled using normal laboratory precautions.

Device Description

The Calibrators for the OEM Instruments are aqueous reagents with salts added to obtain desired analyte levels to provide calibration of the electrodes. The reagents are intended for use on equivalent OEM Instruments. Mission uses a similar composition, description and packaging as that used by the OEM in its products.

AI/ML Overview

The provided document describes the 510(k) submission for Mission ISE Reference & CO2 Reagents. The study aimed to demonstrate substantial equivalence to predicate devices (OEM materials) by comparing performance on an equivalent OEM analyzer.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in a dedicated table format with pass/fail thresholds. Instead, it states: "All analytes tested passed criteria per SOP23-01-02 Performance Study Protocol for 510(k) Submission and performed equally to the OEM." The performance is then presented through precision and correlation data.

Assuming "performed equally to the OEM" implies that the precision and correlation values of the Mission reagents should be comparable to or within acceptable variations of the OEM reagents, the presented data serves as the performance demonstration against this implicit criterion.

Analyte (Matrix)	Performance Metric	Mission Reagent Performance (Range/Value)	Implied Acceptance Criteria (relative to OEM)	Does it meet criteria?
Precision of Serum Controls (CX® Delta)	%CV	Na: 4.4 - 4.5%	Comparable to OEM reagents	Yes (Implied)
		K: 4.59 - 5.10%	Comparable to OEM reagents	Yes (Implied)
		Cl: 4%	Comparable to OEM reagents	Yes (Implied)
		Ca: 3.06 - 5.23%	Comparable to OEM reagents	Yes (Implied)
		CO2: 4.2 - 4.4%	Comparable to OEM reagents	Yes (Implied)
Precision of CSF Controls (CX® Delta)	%CV	Na: 3.8 - 4.9%	Comparable to OEM reagents	Yes (Implied)
		Cl: 3 - 4%	Comparable to OEM reagents	Yes (Implied)
Precision of Urine Controls (CX® Delta)	%CV	Na: 3.8 - 7.5%	Comparable to OEM reagents	Yes (Implied)
		K: 5.6 - 6.4%	Comparable to OEM reagents	Yes (Implied)
		Cl: 4 - 6%	Comparable to OEM reagents	Yes (Implied)
		Ca: 3.99 - 8.97%	Comparable to OEM reagents	Yes (Implied)
Precision of Serum Samples (CX® Delta)	%CV	Ca: 2.5 - 3.6%	Comparable to OEM reagents	Yes (Implied)
Precision of Serum Controls (CX®)	%CV	Na: 0.6 - 0.7%	Comparable to OEM reagents	Yes (Implied)
		K: 0.29 - 0.42%	Comparable to OEM reagents	Yes (Implied)
		Cl: 0.5 - 0.7%	Comparable to OEM reagents	Yes (Implied)
		CO2: 1.3 - 1.4%	Comparable to OEM reagents	Yes (Implied)
Correlation – Serum Values (CX®)	R²	Na: >0.99	High correlation (close to 1) with OEM results	Yes
		K: >0.99	High correlation (close to 1) with OEM results	Yes
		Cl: >0.99	High correlation (close to 1) with OEM results	Yes
		CO2: >0.99	High correlation (close to 1) with OEM results	Yes

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

The sample sizes for the test sets (controls and serum samples) are provided in the tables:

Precision Studies (CX® Delta):
- Serum Controls: N ranges from 27 to 43 per analyte and control level.
- CSF Controls: N ranges from 12 to 13 per analyte and control level.
- Urine Controls: N ranges from 29 to 48 per analyte and control level.
- Serum Samples (Ca): N = 18 per control level.
Precision Studies (CX®):
- Serum Controls: N ranges from 12 to 18 per analyte and control level.
Correlation Studies (CX®):
- Na: N = 62
- K: N = 91
- Cl: N = 76
- CO2: N = 76

Data Provenance:
The document does not explicitly state the country of origin of the data. It refers to testing performed on "CX® Delta and CX® depending on availability," indicating the tests were conducted using Beckman Synchron Delta and CX® systems. The submission is made by "Mission Diagnostics, Holliston MA 01746," suggesting potential US origin for the testing or data collection, but this is not explicitly confirmed. The studies appear to be prospective as they were conducted to generate data for the 510(k) submission, following a defined protocol (SOP23-01-02).

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

This is a device for in-vitro diagnostics (reagents), specifically calibrators. Ground truth for such devices is typically established through a reference method or comparison to an established, validated predicate device (the OEM reagents in this case), not through expert consensus on interpretation. Therefore, the concept of "experts" in the context of radiologists or similar interpretive fields is not applicable here. The "ground truth" is the established performance of the predicate OEM reagents and the analytical accuracy of the instrument.

4. Adjudication Method for the Test Set:

Not applicable. As this is a quantitative analytical device (reagents for calibrating an instrument), there are no human interpretations or classifications that would require adjudication. The performance is assessed through statistical measures like precision and correlation against the predicate.

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. This is not an AI/medical imaging device requiring human reader studies. It is a set of chemical reagents for in-vitro diagnostic use.

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

Not applicable. This is not a software algorithm device. It is a set of chemical reagents.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for demonstrating substantial equivalence for these diagnostic reagents is the analytical performance of the legally marketed predicate devices (OEM reagents) and the analytical accuracy of the Beckman Synchron Delta & CX® Systems. The studies compare the performance of the Mission reagents calibrated system to the OEM reagents calibrated system via method comparison, precision, and correlation. The implicit "ground truth" is that the OEM reagents and the instrument provide accurate measurements.

8. The Sample Size for the Training Set:

The document does not mention a "training set" in the context of device development or validation. This is a chemical reagent product, not a machine learning model, so the concept of a training set is not applicable. The provided data relates to the performance testing (validation) of the new Mission reagents.

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

Not applicable, as there is no training set in this context.

Summary

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K033061

NOV - 7 2003

Summary of 510(k) Submission for Mission ISE Reference & CO2 Reagents for Beckman Synchron Delta & CX® Systems

1. Submitter's Name & AddressMission Diagnostics331 Fiske StHolliston MA 01746FAX: 508-429-0452	Contact PersonLinda StundtnerQA/RA Manager508-429-0450
Establishment Registration Number: 3003656721

Date of Preparation:

Sept 22, 2002

2. Identification of the Device:

Proprietary/Trade name:	Calibrating Material, Reference Buffer
Common or usual name	Calibrators for ISE automated systems
Classification name:	Calibrator, secondary
Device Classification	II
Regulation Number:	21 CFR § 862.1150
Panel:	Chemistry (75)
Product Code:	JIT

Mission manufactures calibrators intended to serve as direct replacements to like named . products (predicate devices) manufactured by Original Equipment Manufactures (OEM)

3. Predicate Device:

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

Substantial Equivalence Table of Product PN's & Trade Names

Mission Product	OEM Equivalent
BK-443320D	CO2 Alkaline Buffer	443320	CO2 Alkaline Buffer
BK-443330D	CO2 Acid	443330	CO2 Acid
BK-450214D	ISE Electrolyte Reference	450214	ISE Electrolyte Reference

. The predicate reagents are encompassed in the 510(k)'s K942676 & K864236 cleared 11/02/1994 & 12/31/1986 respectively.

4. Device Description:

The Calibrators for the OEM Instruments are aqueous reagents with salts added to obtain . desired analyte levels to provide calibration of the electrodes.
Intended Use: ●
. The reagents are intended for use on equivalent OEM Instruments.

510k for Mission ISE Reference & CO2 Reagents on Beckman Synchron Delta & CX® Systems

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. The original equipment manufacturer (OEM) of the instruments and the predicate reagents are necessary for the continued operation and use of the instruments.
. Mission uses a similar composition, description and packaging as that used by the OEM in its products, as shown in the packaging section of this submission.
. Performance equivalence is shown in the following manner:
- . Through a method comparison where results obtained on an equivalent OEM analyzer, calibrated with Mission calibrating material are compared with results obtained on the same analyzer calibrated with OEM calibrating material.
- . A summary of the results of these studies follows:

5. Performance Characteristics:

Precision and correlation data are collected per:

. SOP23-01-02 Performance Study Protocol for 510(k) Submission
Data for each instrument and each run are recorded on SOP23-03F Performance Study . Record Sheet. (See Attachment Section for Copy of Procedures)

All analytes tested passed criteria per SOP23-01-02 Performance Study Protocol for 510(k) Submission and performed equally to the OEM.

Testing was performed on CX® Delta and CX® depending on availability.

Table of Precision of Serum Controls, CSF Controls & Urine Controls on CX® Delta

Analyte	Level	N	Mean	Sd	Min	Max	%CV
Nammol/L	DCtrol 1	43	142.0	6.4	129.6	157.0	4.5
	DCtrol 2	38	155.7	6.9	148.7	174.4	4.4
Kmmol/L	DCtrol 1	43	4.22	0.22	3.88	4.71	5.10
	DCtrol 2	45	8.10	0.37	7.69	9.21	4.59
Clmmol/L	DCtrol 1	43	107	5	98	118	4
	DCtrol 2	38	118	5	113	131	4
Cammol/L	DCtrol 1	31	2.51	0.08	2.39	2.69	3.06
	DCtrol 2	27	3.35	0.18	3.16	4.00	5.23
CO2mmol/L	DCtrol 1	40	14.8	0.7	13.1	16.0	4.4
	DCtrol 2	43	25.4	1.1	23.1	28.2	4.2
Nammol/L	CSF 1	13	127.4	6	119.4	139.0	3.8
	CSF 2	12	159.9	5	153.8	170.3	4.9
Clmmol/L	CSF 1	13	89	4	84	95	4
	CSF 2	12	105	3	102	111	3
Nammol/L	URINE 1	48	65.6	4.9	59.7	77.0	7.5
	URINE 2	44	208.2	7.9	197.1	227.8	3.8
Kmmol/L	URINE 1	48	33.7	2.2	31.5	39.0	6.4
	URINE 2	45	108.4	6.1	101.4	122.9	5.6
Clmmol/L	URINE 1	47	100	6	92	113	6
	URINE 2	47	256	10	245	280	4
Cammol/L	URINE 1	29	1.57	0.14	1.44	1.90	8.97
	URINE 2	32	3.50	0.14	3.27	3.84	3.99

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Analyte	Level	N	Mean	Sd	Min	Max	%CV
Ca mmol/L	Normal	18	2.42	0.06	2.30	2.52	2.5
	Lo	18	1.96	0.06	1.86	2.05	3.1
	High	18	3.65	0.13	3.47	3.84	3.6

Table of Precision of Serum Samples on CX® Delta

Table of Precision of Serum Controls on CX®

Analyte	Level	N	Mean	Sd	Min	Max	%CV
Na mmol/L	DCtrol 1	18	139.7	0.08	138.5	141.1	0.6
Na mmol/L	DCtrol 2	18	154.1	1.03	152.6	156.0	0.7
K mmol/L	DCtrol 1	14	4.07	0.01	4.05	4.08	0.29
K mmol/L	DCtrol 2	12	7.36	0.03	7.89	7.98	0.42
Cl mmol/L	DCtrol 1	18	104	0.5	103	105	0.5
Cl mmol/L	DCtrol 2	18	118	0.8	116	120	0.7
CO2 mmol/L	DCtrol 1	18	14.8	0.2	14.4	15.1	1.4
CO2 mmol/L	DCtrol 2	18	26.5	0.3	25.7	27.1	1.3

Table of Correlation – Serum Values on CX®

Analyte	N	Slope	Intercept	R2	Range
Na	62	0.95	3.59	>0.99	95.4 - 203.4
K	91	0.99	-0.03	>0.99	1.81 - 8.79
Cl	76	0.97	1.49	>0.99	54 - 203
CO2	76	0.93	1.58	>0.99	8 - 30.7

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping profiles, creating a sense of depth and movement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV - 7 2003

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

Re: K033061

Trade/Device Name: Mission Diagnostic ISE Reference & CO2 Reagents for Beckman Synchron Delta & CX® Systems

Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: September 22, 2003 Received: September 29, 2003

Dear Ms. Stundtner:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number K033041

Device Name:

Mission Diagnostic ISE Reference & CO2 Reagents for Beckman Synchron Delta & CX® Systems

Indication For Use:

The three products encompassed by this request are intended for in-vitro diagnostics use. ●

Mission Product
BK-443320D	CO2 Alkaline Buffer
BK-443330D	CO2 Acid
BK-450214D	ISE Electrolyte Reference

Mission Electrolyte Reference Reagent provides reference points for Na, K, CI, Ca (on Delta's only) and . TCO2. When used in conjunction with CO2 Acid Reagent, CO2 Alkaline Buffer and Electrolyte Buffer, the ISE Electrolyte Reference is used for the calibration of the ISE electrodes; sodium, potassium chloride and calcium (on Delta's only) and CO2.
The CO2 Acid reagent is used to release CO2 from samples .
The CO2 Alkaline in used to provide a constant CO2 concentration as reference for the CO2 electrode. .
Mission reagents are intended to serve as direct replacements to the predicate devices manufactured . by the OEM.
The products encompassed are to be handled using normal laboratory precautions. .

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrance of CDRH, Office of the Device Evaluation (ODE)

Carol Benson for Jean Cooper, OVM
Division Sign-Off

o Diagnostic De ation and 22

510(k) K033061

(Optional format 3-10-98)

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.