The products encompassed by this request are intended for in vitro diagnostic use only and are intended for use in the calibration of equivalent Roche/AVL 9100 Series Electrolyte Analyzers.

Device Description

Thermo ALKO Calibration Packs are intended for use on equivalent Roche/AVL 9100 Series Analyzers. Calibration Pack, Product No. A9100-101S, contains Standard A, Standard B, Reference Solution and a waste container. It is intended for calibration of equivalent Roche/AVL 9120 and 9130 Analyzers, Calibration Pack, Product No. A9100-103S, contains Standard B, Standard C, Reference Solution and a waste container. It is intended for calibration of equivalent Roche/AVL 9180 and 9181 Analyzers.

AI/ML Overview

The provided text describes a 510(k) summary for Thermo ALKO Calibration Packs, which are calibration standards for electrolyte analyzers. The study aims to demonstrate that these calibration packs are substantially equivalent to a predicate device (AVL ISE SnapPak™).

Here's an analysis of the acceptance criteria and study details based on the provided information:

Acceptance Criteria and Device Performance

The core acceptance criterion for substantial equivalence in this context is that the Thermo ALKO Calibration Packs perform comparably to the predicate device (AVL ISE SnapPak™) when used with equivalent Roche/AVL Analyzers. This is demonstrated through:

Precision Study: Showing consistent results with the Thermo ALKO Calibration Pack over time.
Method Comparison (Correlation) Study: Showing agreement between results obtained using Thermo ALKO Calibration Packs and those obtained using AVL ISE SnapPak™.

Table of Acceptance Criteria (Implied) and Reported Device Performance

Since this is a submission for substantial equivalence of calibrators, explicit numerical "acceptance criteria" are not given in the traditional sense of a performance target. Instead, the implication is that the precision and correlation values should fall within generally accepted analytical performance ranges for these types of assays, and critically, demonstrate equivalence to the predicate. The presented data are the reported device performance.

Thermo ALKO Calibration Pack, Product Number A9100-101S (for AVL 9130 Analyzer)

Study Type	Analyte	Performance Metric	Reported Device Performance	Implied "Acceptance" (e.g., strong correlation, acceptable precision)
Precision	Na+	Total CV% (Low Level)	0.54%	Acceptable analytical precision
	K+	Total CV% (Low Level)	2.03%	Acceptable analytical precision
	Cl-	Total CV% (Low Level)	1.20%	Acceptable analytical precision
	Na+	Total CV% (High Level)	0.73%	Acceptable analytical precision
	K+	Total CV% (High Level)	1.18%	Acceptable analytical precision
	Cl-	Total CV% (High Level)	1.71%	Acceptable analytical precision
Correlation	Na+	R Squared (vs. Predicate)	0.9993	R-squared close to 1.0 indicates strong correlation
		Slope (vs. Predicate)	0.9796	Slope close to 1.0 indicates good agreement
	K+	R Squared (vs. Predicate)	0.9988	R-squared close to 1.0 indicates strong correlation
		Slope (vs. Predicate)	0.9786	Slope close to 1.0 indicates good agreement
	Cl-	R Squared (vs. Predicate)	0.9989	R-squared close to 1.0 indicates strong correlation
		Slope (vs. Predicate)	0.9818	Slope close to 1.0 indicates good agreement

Thermo ALKO Calibration Pack, Product Number A9100-103S (for AVL 9180 Analyzer)

Study Type	Analyte	Performance Metric	Reported Device Performance	Implied "Acceptance" (e.g., strong correlation, acceptable precision)
Precision	Na+	Total CV% (Low Level)	0.44%	Acceptable analytical precision
	K+	Total CV% (Low Level)	1.08%	Acceptable analytical precision
	Cl-	Total CV% (Low Level)	0.90%	Acceptable analytical precision
	Ca++	Total CV% (Low Level)	2.07%	Acceptable analytical precision
	Li+	Total CV% (Low Level)	2.11%	Acceptable analytical precision
	Na+	Total CV% (High Level)	0.61%	Acceptable analytical precision
	K+	Total CV% (High Level)	0.76%	Acceptable analytical precision
	Cl-	Total CV% (High Level)	0.62%	Acceptable analytical precision
	Ca++	Total CV% (High Level)	2.15%	Acceptable analytical precision
	Li+	Total CV% (High Level)	1.58%	Acceptable analytical precision
Correlation	Na+	R Squared (vs. Predicate)	0.9998	R-squared close to 1.0 indicates strong correlation
		Slope (vs. Predicate)	0.9991	Slope close to 1.0 indicates good agreement
	K+	R Squared (vs. Predicate)	0.9993	R-squared close to 1.0 indicates strong correlation
		Slope (vs. Predicate)	1.0069	Slope close to 1.0 indicates good agreement
	Cl-	R Squared (vs. Predicate)	0.9999	R-squared close to 1.0 indicates strong correlation
		Slope (vs. Predicate)	1.0032	Slope close to 1.0 indicates good agreement
	Ca++	R Squared (vs. Predicate)	0.9994	R-squared close to 1.0 indicates strong correlation
		Slope (vs. Predicate)	1.0073	Slope close to 1.0 indicates good agreement
	Li+	R Squared (vs. Predicate)	0.9994	R-squared close to 1.0 indicates strong correlation
		Slope (vs. Predicate)	0.9930	Slope close to 1.0 indicates good agreement

Study Details:

Sample sizes used for the test set and data provenance:
- Precision Study (A9100-101S on AVL 9130): Two levels of human serum-based materials, analyzed in duplicate per run, over 23 days (25 total runs reported).
- Correlation Study (A9100-101S on AVL 9130): 47 human serum samples and control materials (N=56 for Na+ and K+, N=52 for Cl- in the table).
- Precision Study (A9100-103S on AVL 9180): Two levels of human serum-based materials, analyzed in duplicate per run, over 24 days (22 total runs reported).
- Correlation Study (A9100-103S on AVL 9180): 48 human serum samples and control materials (N=57 for Na+ and K+, N=50 for Cl-, N=55 for Ca++, N=46 for Li+ in the table).
- Data Provenance: The samples are described as "human serum samples and control materials." The country of origin is not specified, nor is whether the data is retrospective or prospective. Given the nature of a 510(k) for a calibrator, it's typically prospective testing performed during development.
Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- This is an analytical performance study for a medical device calibrator, not an diagnostic imaging or AI study requiring human expert interpretation or ground truth in the traditional sense of clinical outcomes or pathology.
- The "ground truth" for the correlation study is implicitly the results obtained using the predicate device (AVL ISE SnapPak™) on the same analyzers. The human serum samples and control materials are measured by both the new device (calibrated with Thermo ALKO packs) and the predicate device (calibrated with AVL ISE SnapPak™), and these results are compared.
Adjudication method for the test set:
- Not applicable. This is not a study requiring adjudication of diagnostic findings. The comparison is quantitative between two analytical methods.
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 an analytical performance study for a calibrator, not a diagnostic imaging or AI study involving human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is an analytical performance study for a calibrator, not an AI algorithm. The performance of the calibrator is assessed alone (precision study) and in comparison to a predicate calibrator (correlation study). There is no "human-in-the-loop" concept in the way it applies to AI-assisted diagnostic devices.
The type of ground truth used:
- For the precision study, there isn't a "ground truth" in the diagnostic sense. The study assesses the repeatability and reproducibility of the device itself (when calibrated with the Thermo ALKO packs).
- For the correlation study, the "ground truth" or reference method is the predicate device (AVL ISE SnapPak™). The performance of the Thermo ALKO packs is measured against the established performance of the legally marketed predicate device.
The sample size for the training set:
- Not applicable. This device is a calibrator, not a machine learning or AI algorithm, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.

Summary

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510(k) Summary for Thermo ALKO Calibration Packs for use on Equivalent AVL 9100 Series Electrolyte Analyzers

1. Submitter's Name and Address:

Thermo Orion, Inc. Thermo ALKO 500 Cummings Center Beverly, MA 01915

Contact Person:

Patrick K. Chiu Quality Assurance Manager Thermo ALKO products (978) 232-6054

Date of Preparation: November 12, 2002

2. Device Identification:

Proprietary name/Trade name:	Calibration Pack
Common or usual name:	Calibration Standards for Electrolyte (ISE) Analyzers
Classification name:	Calibrator, Multi-Analyte Mixture
Device Classification:	II
Regulation Number:	21 CFR 862.1150
Panel:	Clinical Chemistry (75)
Product Code:	JIX

Substantial Equivalence: 3.

Thermo ALKO Calibration Packs, Product No. A9100-101S and A9100-103S, are claimed to be substantially equivalent to AVL ISE SnapPak™, Product Number BP5016 and BP5186, respectively, (encompassed in the 510(k) under the device name "AVL 9180 Electrolyte Analyzer", 510(k) number K961458 previously cleared by the FDA on 06/12/1996), manufactured and distributed by Roche Diagnostics (AVL Scientific).

Device Description: 4.

A VL Scientific, a trade name owned by Roche Diagnostics, is the original equipment manufacturer (OEM) of the analyzers and of predicate device (ISE SnapPak™) which is necessary for the continued operation and use of the analyzers. The Roche/AVL 9100 Series Analyzers perform electrolyte tests wherein samples are analyzed for the quantitative determinations of electrolytes by Ion Selective Electrode (ISE) method. Both Roche/AVL 9120 and 9130 Analyzers can measure Na and K* with the exception that the Roche/AVL 9130 also measures CI in addition to Na ' and K '. Both Roche/AVL 9180 and 9181 Analyzers can measure Nat, K+, CJ , Ca+ , and Li+ with the exception that the Roche/AVL 9181 has an added autosampler.

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Thermo ALKO Calibration Packs are intended to be used with equivalent Roche/AVL Analyzers. As such, Thermo Orion (Thermo ALKO) products are intended to serve as direct replacements to like named products manufactured and distributed by Roche Diagnostics (AVL Scientific).

Thermo Orion (Thermo ALKO) uses a similar composition and packaging design as that used by Roche Diagnostics (AVL Scientific) in its products. Thermo Orion (Thermo ALKO) has shown performance equivalence of its products to the Roche Diagnostics (AVL Scientific) products in the following manner:

O Through a method comparison where results are obtained on equivalent Roche/AVL Analyzers, calibrated with Thermo Orion (Thermo ALKO) products and are compared with results obtained on the same Analyzers calibrated with Roche Diagnostics (AVL Scientific) products; and
Through a precision study where Thermo Orion (Thermo ALKO) products were installed on equivalent Roche/AVL Analyzers and samples were measured in multiple runs over a defined period.

A summary of the results of these studies follows:

న్. Performance Characteristics:

Thermo ALKO Calibration Pack, Product Number A9100-101S:

Precision Data

Precision data were collected from the analysis of two levels of human serum based materials in duplicate per run on an AVL 9130 analyzer over a period of 23 days calibrated with Thermo ALKO Calibration Pack.

Level	Analyte	Ttl Runs	Mean	Ttl SD	Ttl CV%	WR SD	WR CV%
Level 1	Na+	25	116.4	0.63	0.54	0.34	0.29
	K+	25	2.71	0.055	2.03	0.017	0.62
	Cl-	25	103.6	1.24	1.20	0.32	0.31
Level 2	Na+	25	149.8	1.09	0.73	0.36	0.24
	K+	25	6.09	0.072	1.18	0.029	0.47
	Cl-	25	139.9	2.39	1.71	0.32	0.23

WR SD = within-run standard deviation Ttl SD = total standard deviation

Correlation Data

Correlation data were obtained from 47 human serum samples and control materials for Na . K and Cli measured on an AVL 9130 Analyzer, calibrated with Thermo ALKO Calibration Pack and AVL ISE SnapPak™, separately. Linear Regression Analysis was performed using Thermo ALKO Data as the Dependent Y Variable and AVL Data as the Independent X Variable in the equation Y = a + bX. Values of R Squared are 0.9993 for Nat, 0.9988 for K+ and 0.9989 for Cli. Values of slopes are 0.9796 for Nat, 0.9786 for K+ and 0.9818 for Cl .

Analyte	(N)	Slope	Intercept	R Sq	Range (mM)
Na+	56	0.9796	2.2385	0.9993	65.1 to 187.6
K+	56	0.9786	0.0633	0.9988	1.80 to 11.5
Cl-	52	0.9818	2.0605	0.9989	50.1 to 163.5

R Sq = Correlation coefficient Squared

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Thermo ALKO Calibration Pack, Product Number A9100-103S:

Precision Data

Precision data were collected from the analysis of two levels of human serum based materials in duplicate per run on an AVL 9180 analyzer over a period of 24 days calibrated with Thermo ALKO Calibration Pack.

Level	Analyte	Ttl Runs	Mean	Ttl SD	Ttl CV%	WR SD	WR CV%
Level 1	Na+	22	115.8	0.51	0.44	0.41	0.35
	K+	22	2.71	0.029	1.08	0.017	0.62
	Cl-	22	101.5	0.91	0.90	0.27	0.27
	Ca++	22	0.90	0.019	2.07	0.016	1.80
	Li+	22	1.025	0.022	2.11	0.013	1.31
Level 2	Na+	22	149.5	0.91	0.61	0.36	0.24
	K+	22	6.21	0.047	0.76	0.036	0.57
	Cl-	22	141.2	0.88	0.62	0.40	0.29
	Ca++	22	1.71	0.037	2.15	0.031	1.80
	Li+	22	2.906	0.046	1.58	0.011	0.39

WR SD = within-run standard deviation

Ttl SD = total standard deviation

Correlation Data:

Correlation data were obtained from 48 human serum samples and control materials for Na , K , Cl , Cat and Li+ measured on an AVL 9180 Analyzer, calibrated with Thermo ALKO Calibration Pack and AVL ISE SnapPak™, separately. Linear Regression Analysis was performed using Thermo ALKO Data as the Dependent Y Variable and AVL Data as the Independent X Variable in the equation Y = a + bX. Values of R Squared are 0.9998 for Na , 0.9993 for K, 0.9999 for Cl', 0.9994 for Ca" and 0.9994 for Lit. Values of slopes are 0.9991 for Nat, 1.0069 for K , 1.0032 for Cl~, 1.0073 for Ca** and 0.9930 for Li*.

Analyte	(N)	Slope	Intercept	R Sq	Range (mM)
Na+	57	0.9991	-0.3118	0.9998	65.0 to 198.4
K+	57	1.0069	-0.0513	0.9993	1.75 to 12.03
Cl-	50	1.0032	-0.4125	0.9999	55.3 to 174.9
Ca++	55	1.0073	-0.0166	0.9994	0.24 to 4.91
Li+	46	0.9930	-0.0089	0.9994	0.21 to 5.63

R Sq = Correlation Coefficient Squared

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines suggesting hair or fabric. The profiles are arranged in a stacked formation, creating a sense of depth and unity. Encircling the image is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 3 1 2003

Mr. Patrick K. Chiu Quality Assurance Manager Thermo Orion, Inc. 500 Cummings Center Beverly, MA 01915

K023792 Re:

Trade/Device Name: Calibration Packs for use on equivalent Roche/AVL 9100 Electrolyte Analyzers Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: November 12, 2002 Received: November 13, 2002

Dear Mr. Chiu:

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. Iisting 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). 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

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: K023792

Calibration Packs for use on equivalent Roche/AVL 9100 Series Electrolyte Device Name: Analyzers

Indications For Use:

The products encompassed by this request are intended for in vitro diagnostic use only and are intended for use in the calibration of equivalent Roche/AVL 9100 Series Electrolyte Analyzers .

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Division of Clinical Laboratory Devices
510(k) Number K023792

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use \ (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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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.