K Number

Device Name

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

Manufacturer

DIAMOND DIAGNOSTICS, INC.

Date Cleared

2001-12-21

(31 days)

Product Code

JIT

Regulation Number

862.1150

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

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Not Found (Predicate devices are identified by name of product, not K/DEN number in the document)

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes calibrators and reagents for in-vitro diagnostic analyzers, focusing on chemical composition and performance equivalence studies. There is no mention of AI, ML, or related concepts.

Therapeutic

No
The device is intended for in-vitro diagnostics use and functions as an aqueous reagent for calibrating laboratory analyzers, not for direct therapeutic treatment of patients.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states "The products encompassed by this request are intended for in-vitro diagnostics use".

SaMD (Software as a Medical Device)

The device description explicitly states the device is an "aqueous reagent with salts added," which is a chemical substance, not software. The summary focuses on the performance of these reagents in calibrating and flushing hardware analyzers.

IVD (In Vitro Diagnostic)

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 (Calibrators) is used to calibrate and rinse the sample flow path of analyzers that measure analytes (like Na, K, Cl, Ca, and Li) in biological samples (human serum). This process is performed in vitro (outside the body) to provide diagnostic information.
Context: The device is intended for use with AVL 98X series Analyzers, which are themselves IVD devices used for clinical testing.

The description clearly aligns with the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The reagents are intended for use on equivalent AVL Electrolyte Instruments. AVL is the original rougents and intended for a of the instruments and the predicate reagents which are necessary for the continued operation and use of the instruments. The Mission reagents are intended to serve as direct replacements to like named products manufactured by AVL.

Product codes (comma separated list FDA assigned to the subject device)

JIT

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.

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 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.

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.

Table 1 (983 AVL Electrolyte Instrument):
- Na: N=48 for QC1, N=44 for QC2, N=48 for QC3. Mean ranges from 117.2 to 166.9. %CV ranges from 0.42% to 0.92%.
- K: N=48 for QC1, N=45 for QC2, N=48 for QC3. Mean ranges from 1.97 to 7.10. %CV ranges from 0.72% to 3.65%.
- Cl: N=48 for QC1, N=45 for QC2, N=48 for QC3. Mean ranges from 84.7 to 133.8. %CV ranges from 0.66% to 2.48%.
Table 2 (984 AVL Electrolyte Instrument):
- Na: N=51 for QC1, N=49 for QC2, N=51 for QC3. Mean ranges from 117.3 to 165.1. %CV ranges from 0.64% to 1.15%.
- K: N=49 for QC1, N=49 for QC2, N=51 for QC3. Mean ranges from 2.07 to 7.03. %CV ranges from 0.58% to 2.66%.
- Ca: N=50 for QC1, N=48 for QC2, N=50 for QC3. Mean ranges from 0.56 to 2.00. %CV ranges from 1.72% to 2.21%.
Table 3 (985 AVL Electrolyte Instrument):
- Na: N=48 for QC1, N=47 for QC2, N=48 for QC3. Mean ranges from 118.6 to 166.5. %CV ranges from 0.33% to 0.95%.
- K: N=48 for QC1, N=47 for QC2, N=48 for QC3. Mean ranges from 2.07 to 7.01. %CV ranges from 0.84% to 3.23%.
- Li: N=47 for QC1, N=47 for QC2, N=48 for QC3. Mean ranges from 0.29 to 2.13. %CV ranges from 1.63% to 2.20%.

Correlation with AVL Reagents (Regression Analysis of Mission vs AVL Human Serum Results):

Na:
- 983: N=153, Slope=0.9859, Intercept=2.13, R2=0.9989, Range=66-178
- 984: N=135, Slope=1.011, Intercept=-1.50, R2=0.9985, Range=66-176
- 985: N=161, Slope=1.024, Intercept=-3.42, R2=0.999, Range=67-178
K:
- 983: N=153, Slope=0.9777, Intercept=0.12, R2=0.9984, Range=2.41-6.64
- 984: N=135, Slope=1.0034, Intercept=0.03, R2=0.9989, Range=2.48-6.43
- 985: N=162, Slope=1.0094, Intercept=-0.02, R2=0.9987, Range=2.45-6.52
Other Analytes:
- 983 Cl: N=151, Slope=0.9669, Intercept=3.97, R2=0.9984, Range=52-162
- 984 Ca: N=134, Slope=0.9004, Intercept=0.07, R2=0.9859, Range=0.67-2.25
- 985 Li: N=132, Slope=1.0144, Intercept=-0.02, R2=0.9940, Range=0.33-2.55

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found (Predicate devices are identified by name of product, not K/DEN number in the document)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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: 508-429-0452

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.

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.

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%

Precison Data Table 2 984 AVL Electrolyte Instrument

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

AVL	984
-----	-----

	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%

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

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

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.

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 (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 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

510(k( Number K013850

Device Name: Mission Diagnostic Reagents for AVL 98X Analyzers

Indication For Use:

| Mission PN | | 98X AVL Instrument
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