The Elecsys Toxo IgG CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Toxo IgG reagent on the Elecsys 2010, MODULAR ANALYTICS E170 and cobas e immunoassay analyzers.

Device Description

The Elecsys Toxo IgG CalCheck 5 is a lyophilized product consisting of a defined concentration of human anti-Toxoplasma gondii IgG antibodies in a human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.

AI/ML Overview

The provided text describes the Elecsys Toxo IgG CalCheck 5, an assayed control device used for calibration verification and assay range verification for Elecsys Toxo IgG reagent on specific immunoassay analyzers.

Here's an analysis to extract the requested information:

1. A table of acceptance criteria and the reported device performance

The document states: "Each laboratory should establish appropriate acceptance criteria when using this product for its intended use." It then provides "approximate target ranges" and instructs to "Refer to the value sheet located on www.MyLabOnline.com for lot-specific ranges."

Therefore, the acceptance criteria are to be established by individual laboratories, and the reported device performance is presented as target ranges.

Level	Approximate Target Range	Unit
Check 1	$\leq$ 1.00	IU/mL
Check 2	2.10 - 3.90	IU/mL
Check 3	228 - 423	IU/mL
Check 4	364 -> 650	IU/mL
Check 5	455 -> 650	IU/mL

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document implicitly describes "test sets" as the use of the CalCheck 5 levels themselves for verification.

For calibration verification only, "recommended levels are Check 2, 3 and 4." Each level is run in duplicate. This forms a test set of 6 samples (3 levels x 2 replicates).
For verification of assay range (or both assay range and calibration verification), "recommended levels are Check 1, 2, 3, 4 and 5." Each level is run in duplicate. This forms a test set of 10 samples (5 levels x 2 replicates).

The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given that it is a submission for a 510(k) in the US, it's reasonable to infer data would support US regulatory requirements, but it's not explicitly stated. It describes instructions for how a user should run the checks, rather than detailing a specific pre-market study's data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This device is a control material, not a diagnostic device that interprets patient data. The "ground truth" for the test set (the CalCheck 5 solutions) is their assigned value, which is traceable to an international standard. The document states: "The assay value of each level was calibrated against the WHO anti-Toxoplasma serum (TOXM), 3rd International Standard for T. gondii from NIBSC, UK." Therefore, the ground truth is established against a recognized international standard, not by experts in the sense of clinical interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is a control material for laboratory calibration and assay range verification, not a diagnostic device requiring human adjudication of results. The method of verification involves comparing the average value of duplicate runs to a specified acceptable range provided in a lot-specific value sheet. If results are outside the range, troubleshooting steps are outlined (repeat testing, contact technical support).

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 a control material for calibration and assay range verification in an immunoassay system. It does not involve human readers interpreting cases or AI assistance.

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

Not applicable. This is a physical control material used in conjunction with an immunoassay analyzer and reagents. It's not a standalone algorithm.

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

The ground truth for the Elecsys Toxo IgG CalCheck 5 levels is primarily traceability to an international standard: "The assay value of each level was calibrated against the WHO anti-Toxoplasma serum (TOXM), 3rd International Standard for T. gondii from NIBSC, UK."

8. The sample size for the training set

Not applicable. This is a control material, not a machine learning model that requires a training set. Its values are assigned through calibration to a reference standard during manufacturing.

9. How the ground truth for the training set was established

Not applicable for the same reason as above.

Summary

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Image /page/0/Picture/0 description: The image shows a handwritten string of characters. The characters appear to be a combination of numbers and letters. The string reads 'K092888-S'.

NOV 1 0 2009

According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence. Submitter Roche Diagnostics Name, Address, 9115 Hague Road Contact Indianapolis, IN 46250 Information 317-521-3952 Contact Person: Jane Phillips Phone: 317-521-3338 Fax: 317-521-2324 Email: jane.phillips@roche.com Secondary Contact: Stephanie Greeman Phone: 317-521-2458 Fax: 317-521-2324 Email: stephanie.greeman@roche.com Date Prepared: September 8, 2009 Device Name Proprietary name: Elecsys Toxo IgG CalCheck 5 Common name: Toxo IgG CalCheck 5 Classification name: Single (specified) analyte controls (assayed and unassayed) The Elecsys Toxo IgG CalCheck 5 is substantially equivalent to the Elecsys Predicate Device Toxo IgG CalCheck (K083655). The Elecsys Toxo IgG CalCheck 5 is a lyophilized product consisting of a Device Description defined concentration of human anti-Toxoplasma gondii IgG antibodies in a human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. The Elecsys Toxo IgG CalCheck 5 is an assayed control for use in calibration Intended Use verification and for use in the verification of the assay range established by the Elecsys Toxo IgG reagent on the Elecsys 2010, MODULAR ANALYTICS E170 and cobas e immunoassay analyzers.

510(k) Summary

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510(k) Summary, Continued

The table below compares Elecsys Toxo IgG CalCheck 5 with the predicate ' Comparison Table device, Elecsys Toxo IgG Calcheck (K083655).

Characteristic	Elecsys Toxo IgG CalCheck(K083655)	Elecsys Toxo IgG CalCheck 5
Intended Use	The Elecsys Toxo IgG CalCheck, an assayed calibrator control, is intended for use in the verification of the calibration established by the Elecsys Toxo IgG reagent on the Elecsys 2010, the MODULAR ANALYTICS E170 and cobas e immunoassay analyzers.	The Elecsys Toxo IgG CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Toxo IgG reagent on the Elecsys 2010, MODULAR ANALYTICS E170 and cobas e immunoassay analyzers.
Levels	Three	Five
ReactiveComponent	Anti-Toxo IgG antibody	Same
Format	Lyophilized	Same
Handling	Reconstitute the contents of each vial with exactly 1.0 mL distilled or deionized water. Allow the bottle to stand closed for 15 minutes. Mix gently by inversion to ensure homogeneity.	Same
Stability	Unopened:• Store at 2-8°C until expiration dateReconstituted:• 20 – 25°C : 4 hrs	Same
Matrix	Human serum matrix	Same
Preservatives	None	Same
Traceability	The assay value of each level was calibrated against the WHO anti-Toxoplasma serum (TOXM), 3rd International Standard for T. gondii from NIBSC, UK.	Same

Performance Characteristics

The Elecsys Toxo IgG CalCheck 5 was evaluated for value assignment and stability.

and the same of the same of the same of the same of the same of the same of the same of

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G CalCheck 5 (Draft)

for 5 x 1.0 mlL

IgG antibodies to Toxoplasma gondii

HEF 05979650 160

· Indicates analyzers on which the kit can be used

Elecsys 2010	MODULARANALYTICS E170	cobas e 411	cobas e 601
•	•	•	•

English

Intended use

Summary

Elecsys Toxo IgG CalCheck 5 set contains 5 Iyophilized levels of human anti-Toxo IgG antibodies in a solution of human serum protein and has the appropriate matrix characteristics for the analyte. The solutions assist in the documentation of calibration verification and verification of the assay range.

Principle

Calibration verification is not a requirement of the Elecsys and cobas e immunoassay systems based on the manufacturer's recommendations. However, in instances where such a test procedure is required by certification agencies, or where the user wishes to document calibration verification, these CalCheck 5 solutions provide an appropriate material for such testing. College of American Pathologists. CAP, defines Calibration Verification by referring to two distinct processes: 1) validation of the current method calibration and 2) validation of the reportable range.1

CAP defines the ANALYTICAL MEASUREMENT RANGE (AMR) as the range of analyte values that a method can directly measure on the specimen without any dilution, concentration, or other pretreatment not part of the usual assay process.1

Reagents - working solutions

Check 1 - 5

Each set contains 5 lyophilized levels

Each bottle, reconstituted to 1.0 mL

Reactive ingredient (after reconstitution):

Toxo IgG antibody positive human serum in human serum matrix

Precautions and warnings

For in vitro diagnostic use.

Exercise the normal precautions required for handling all laboratory reagents. Disposal of all waste material should be in accordance with local guidelines. Safety data sheet available for professional user on request.

All human material should be considered potentially infectious. All products derived from human blood are prepared exclusively from the blood of donors tested individually and shown to be free from HBsAg and antibodies to HCV and HIV. The testing methods applied were FDA-approved or cleared in compliance with the European Directive 98/79/EC, Annex II, List A. However, as no testing method can rule out the potential risk of infection with absolute certainty, the material should be treated just as carefully as a patient specimen. In the event of exposure the directives of the responsible health authorities should be followed.2.3 Avoid the formation of foam with all reagents and sample types (specimens, calibrators, and controls).

Reagent handling ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Reconstitute the contents of Check 1, Check 2, Check 3, Check 4 and Check 5 with exactly 1.0 ml. distilled or deionized water. Allow the bottles to stand closed for 15 minutes. Mix gently by inversion to ensure homogeneity. Refer to the lot-specific value sheet located on www.MyLabOnline.com for any lot-specific reconstitution changes.

Storage and stability

Store unopened at 2-8 ℃. Stability unopened: up to the expiration date printed on the bottle labels at 2-8 ℃. Stability reconstituted: 4 hours at 20-25 ℃.

Materials provided

Elecsys Toxo IgG CalCheck 5 Check 1, 2, 3, 4 and 5

Materials required (but not provided)

Elecsys 2010, MODULAR ANALYTICS E170 or cobas e analyzer
Elecsys Toxo IgG reagent kit
Distilled or deionized water
General laboratory equipment

Assay

· For calibration verification only, recommended levels are Check 2, 3 and 4.

1. Run each Elecsys Toxo IgG CalCheck 5 level in duplicate on the Elecsys or cobas e analyzer. Program the 6 samples as you would patient samples.
Determine the average value for each level and compare it to the 2. appropriate acceptable range listed in the electronically available value sheet. The average value should fall within the specified limits.

If...	Then...
Check 2, Check 3 or Check 4 doesnot fall within the specified limits,	repeat to exclude error in technique.If recovery is still outside thespecified limits, contact CustomerTechnical Support.

· For verification of the assay range only or verification of assay range and calibration verification, recommended levels are Check 1, 2, 3, 4 and 5.

1. Run each Elecsys Toxo IgG CalCheck 5 level in duplicate on the Elecsys or cobas e analyzer. Program the 10 samples as you would patient samples.
Determine the average value for each level and compare it to the 2. appropriate acceptable range listed in the electronically available value sheet. The average value should fall within the specified limits.

lf	Then
Check 1 extends below themeasuring range,	mix equal parts of Check 1 andCheck 2. Analyze the dilutedsample in duplicate. This resultsin values above the low end of theassay range but below the valuefor Check 2. If recovery is stilloutside the specified limits, contactCustomer Technical Support.
Check 5 exceeds the measuringrange,	mix equal parts of Check 4 andCheck 5. Analyze the diluted samplein duplicate. If recovery is stilloutside the specified limits, see nextstep.
the diluted sample of Check 4 andCheck 5 from the previous step stillexceeds the measuring range,	mix equal parts of Check 3 andCheck 5. Analyze the diluted samplein duplicate. If recovery is stilloutside the specified limits, contactCustomer Technical Support.
Check 2, Check 3 or Check 4 doesnot fall within the specified limits,	repeat to exclude error in technique.If recovery is still outside thespecified limits, contact CustomerTechnical Support.

Note

To ensure sufficient volume to run the samples, it is recommended to use 250 µL.

Image /page/2/Picture/48 description: The image shows the logo for Cobas. The logo is in black and consists of the word "cobas" in a sans-serif font. There are parenthesis-like shapes around the first "o" in the word. A registered trademark symbol is located to the upper right of the letter "s".

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Toxo IgG CalCheck 5 (Draft)

Image /page/3/Picture/1 description: The image shows the word "cobas" in a bold, sans-serif font. The "o" in "cobas" has two curved lines on either side of it, resembling sound waves. A circled "R" symbol is located to the upper right of the "s" in "cobas", indicating that the word is a registered trademark.

IgG antibodies to Toxoplasma gondit

Results

Each laboratory should establish appropriate acceptance criteria when using this product for its intended use. Actual results obtained may vary depending on instrumentation. Results may also be dependent on the accuracy of the instrument/reagent/system calibration.

The following table lists approximate target ranges.

Refer to the value sheet located on www.MyLabOnline.com for lot-specific ranges.

Level	Approximate TargetRange	Unit
Check 1	$\leq$ 1.00	IU/mL
Check 2	2.10 - 3.90	IU/mL
Check 3	228 - 423	IU/mL
Check 4	364 -> 650	IU/mL
Check 5	455 -> 650	IU/mL

Traceability

The assay value of each level was calibrated against the WHO anti-Toxoplasma serum (TOXM), 3rd International Standard for T. gondii from NIBSC, UK.

Limitations

Elecsys Toxo IgG CalCheck 5 solutions are intended for use in the confirmation of assay calibration and verification of the assay range. This product is not intended to replace calibration or quality control materials. Refer to the appropriate operator's manual and/or package insert for analyzer-specific limitations.

Symbol legend

K	Use by
(LOT)	Batch code
CONTENT	Contents of kit
100	Manufacturer
IVD	In Vitro Diagnostic Medical Device
r	Temperature limitation (Store at)
ক্তি	Biological risks (Potentially biohazardous material)
REF	Cataloque number

References

College of American Pathologists User's Guide: Calibration 1. Verification/Linearity Surveys. Chapter 3.
Occupational Safety and Health Standards: bloodborne pathogens 2. (29 CFR Part 1910.1030). Fed. Register.
1. Council Directive (2000/54/EC). Official Journal of the European Communities No. L262 from Oct. 17, 2000.

FOR US CUSTOMERS ONLY: LIMITED WARRANTY

Roche Diagnostics warrants that this product will meet the specifications stated in the labeling when used in accordance with such labeling and will be free from defects in material and workmanship until the expiration date printed on the label. THIS LIMITED WARRANTY IS IN LIEU OF ANY OTHER WARRANTY, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR PARTICULAR PURPOSE. IN NO EVENT SHALL ROCHE DIAGNOSTICS BE LIABLE FOR INCIDENTAL. INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES.

COBAS, COBAS E, ELECSYS, MODULAR and MYLABONLINE are trademarks of Roche. Significant additions or changes are indicated by a change bar in the margin. C 2009, Roche Diagnostics

Roche Diagnostics GmbH, Sandhofer Strasse 116, D-68305 Mannheim www.roche.com

Distribution in USA by: Bloche Diagnostics, Inchanapolis, IN
US Customer Technical Support 1-800-428-2336

Image /page/3/Picture/23 description: The image shows the Roche logo. The logo consists of the word "Roche" in bold, sans-serif font, enclosed within a hexagon. The hexagon is outlined in black, and the word "Roche" is also in black.

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Image /page/4/Picture/0 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" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized, curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Scrvice

Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

Jane Ellen Phillips Regulatory Principal Roche Diagnostic Corp. 9115 Hague Road Indianapolis, IN 46250

NOV 1 0 2009

Re: K092888

Trade/Device Name: Elecsys Toxo IgG CalCheck 5 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX, LGD Dated: September 18, 2009 Received: September 21, 2009

Dear Ms. Phillips:

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.

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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). 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 entilled, "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,

Sally Attridge

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

Elecsys Toxo IgG CalCheck 5 Device Name:

Indications For Use: The Elecsys Toxo IgG CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Toxo IgG reagent on the Elecsys 2010, MODULAR ANALYTICS E170 and cobas e immunoassay analyzers.

Prescription Use XXX (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C) . .

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Lueddie lu. Rooly

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K092888

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.