Calibrator for automated systems (C.f.a.s) is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets.

C.f.a.s. (Calibrator for automated systems) CK-MB is for use in the calibration of Roche methods for the quantitative determination of CK-MB on Roche clinical chemistry analyzers as specified in the value sheets.

Device Description

C.f.a.s. is for use in the calibration for automated Roche methods on Roche chemistry analyzers as specified in the enclosed value sheet. It is a lyophilized calibrator based on human serum.
C.f.a.s. CK-MB is for use in the calibration of Roche methods for the quantitative determination of the MB Isoenzyme of Creatine kinase on automated clinical chemistry analyzers. It is a lyophilized calibrator based on bovine serum albumin.

AI/ML Overview

The provided text describes modifications to two calibrator devices, Calibrator for automated systems (C.f.a.s.) and C.f.a.s. CK-MB, and establishes substantial equivalence to predicate devices. However, it does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in a performance study report for diagnostic devices. The document is a 510(k) Summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed performance study with acceptance criteria.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what cannot:

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

The document does not specify quantitative acceptance criteria (e.g., accuracy, precision targets) for the modified calibrators or report specific device performance against such criteria. It primarily focuses on comparing features and source materials to demonstrate substantial equivalence to previously cleared devices.

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

This information is not provided in the 510(k) Summary. Performance data (if collected) would typically be in a separate study report, which is not part of this summary.

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 information is not relevant to a calibrator device and is not provided. Ground truth for calibrators is typically established through reference methods and reference materials, not expert consensus as in image-based diagnostics.

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

This information is not relevant to a calibrator device and is not provided.

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

This type of study is not relevant to a calibrator device and was not conducted. The devices are calibrators for automated chemistry analyzers, not AI-assisted diagnostic tools.

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

This refers to AI algorithm performance studies, which are not relevant to these calibrator devices.

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

For calibrators, the "ground truth" or reference values are established through reference materials and reference methods, as noted in the "Traceability" section:

C.f.a.s.: Uses Reference Materials like SRM 909b, SRM 956, SRM 929, SRM 914, SRM 967, SRM 1951, ERM DA470k, and USP Primary Reference Material. It also references updated IFCC Manuals for various enzymes as reference method publications.
C.f.a.s. CK-MB: The traceability is described as being "described in the reagent system instructions for use," and value assignment is performed by running new lots against previously assigned lots and verifying with reference material, Master lot C.f.a.s. CK-MB, and previously assigned lots.

8. The sample size for the training set

This is not applicable as this is a calibrator device, not an AI algorithm that requires a training set.

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

This is not applicable for the same reason as point 8.

Summary of Provided Information:

The 510(k) Summary describes modifications to two calibrator devices (C.f.a.s. and C.f.a.s. CK-MB) primarily involving changes in the source materials for certain analytes. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices (K062319 for C.f.a.s. and K003158 for C.f.a.s. CK-MB).

C.f.a.s. modifications: Human recombinant Gamma-glutamyltransferase (γGT) replaces porcine kidney γGT; Human recombinant Aspartate aminotransferase (AST) replaces porcine heart AST.
C.f.a.s. CK-MB modifications: Human recombinant Creatine Kinase Isoenzyme MB (CK-MB) replaces porcine brain Creatine Kinase Isoenzyme BB (CK-BB).

The document does not report specific acceptance criteria or a study demonstrating the modified devices meet new performance targets because the purpose of a 510(k) Summary for such device modifications is to show that the changes do not raise new questions of safety and effectiveness and that the modified device is substantially equivalent to an existing legally marketed device. The focus is on comparing features, intended use, format, stability, levels, reagent composition, traceability, value assignment, and source materials with the predicate devices.

Summary

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510(k) Summary – Calibrator for Automated Systems (C.f.a.s.) and C.f.a.s. CK-MB

Introduction	Roche Diagnostics Corporation hereby submits this 510(k) to provide notification of modifications to our Calibrator for automated systems (C.f.a.s.) and C.f.a.s. CK-MB.1. C.f.a.s. was originally cleared for use in K990460, then modified in K033501 and K062319.2. C.f.a.s. CK-MB was originally cleared for use in K003158.Modifications to these devices include changing common source materials for three analytes Human recombinant Gamma-glutamyltransferase (γGT) will replace porcine kidney γGT in C.f.a.s. Human recombinant Aspartate aminotransferase (AST) will replace porcine heart AST in C.f.a.s. Human recombinant Creatine Kinase Isoenzyme MB (CK-MB) will replace porcine brain Creatine Kinase Isoenzyme BB (CK-BB) in C.f.a.s. CK-MB.
Submitter name, address, contact	Roche Diagnostics9115 Hague Rd.PO Box 50416Indianapolis, IN 46250Phone: (317) 521-3380Fax: (317) 521-2324Contact Person: Susan HollandbeckDate prepared: June 16, 2010
	and C.f.a.s. CK-MB, Continued
Device names	Proprietary names:1. Roche Diagnostics Calibrator for automated systems2. Roche Diagnostics Calibrator for automated systems CK-MB
	Common names:1. C.f.a.s.2. C.f.a.s. CK-MB
	Classification names:1. Calibrator, Multi-analyte mixture2. Calibrator, Secondary
	Product Codes:1. JIX2. JIT
Devicedescription	1. C.f.a.s. is for use in the calibration for automated Rochemethods on Roche chemistry analyzers as specified in theenclosed value sheet. It is a lyophilized calibrator based onhuman serum.2. C.f.a.s. CK-MB is for use in the calibration of Roche methodsfor the quantitative determination of the MB Isoenzyme ofCreatine kinase on automated clinical chemistry analyzers. Itis a lyophilized calibrator based on bovine serum albumin.
Intended use	1. Calibrator for automated systems (C.f.a.s.) is for use in thecalibration for automated Roche methods on Roche chemistryanalyzers as specified in the value sheets.2. C.f.a.s. (Calibrator for automated systems) CK-MB is for usein the calibration of Roche methods for the quantitativedetermination of CK-MB on Roche clinical chemistryanalyzers as specified in the value sheets.
Predicatedevices	We claim substantial equivalence to the following currently marketeddevices.1. Calibrator for automated systems cleared in K062319.2. Calibrator for automated systems CK-MB cleared in K003158.Continued on next page
Feature	C.f.a.s(Modified Device)	C.f.a.s. K062319(Predicate Device)
Intended Use	Calibrator for automated systems(C.f.a.s.) is for use in the calibration ofquantitative Roche methods on Rocheclinical chemistry analyzers asspecified in the value sheets.	Calibrator for automated systems(C.f.a.s) is for use in the calibration ofquantitative Roche methods on Rocheclinical chemistry analyzers asspecified in the lot specific valuesheet.
Format	Lyophilized	Same
Stability	Lyophilized calibrator2 to 8 °C until expiration dateReconstituted calibrator15 to 25 °C for 8 hours2 to 8 °C for 2 days-15 to -25 °C for 4 weeks (whenfrozen once)Total Bilirubin in reconstitutedcalibrator when stored protected fromlight15 to 25 °C for 6 hours2 to 8 °C for 1 day-15 to -25 °C for 2 weeks (whenfrozen once)Direct Bilirubin in reconstitutedcalibrator when stored protected fromlight15 to 25 °C for 3 hours2 to 8 °C for 8 hours-15 to -25 °C for 2 weeks (whenfrozen once)	Same
Levels	Single level	Same
Reagent Composition	Lyophilized human serum withchemical additives and material ofbiological origin	Same

Continued on next page

ﺯ ۰

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510(k) Summary – Calibrator for Automated Systems (C.f.a.s.)

and C.f.a.s. CK-MB. Continued

Page 2 of 7

Continued on next p

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510(k) Summary – Calibrator for Automated Systems (C.f.a.s.) and C.f.a.s. CK-MB, Continued

Tables 1 and 2 compare the features of the modified devices with their Substantial equivalence predicate devices. The first is a comparison of C.f.a.s.; the second is a comparison for C.f.a.s. CK-MB.

Table 1: Comparison of C.f.a.s.

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510(k) Summary -- Calibrator for Automated Systems (C.f.a.s.) and C.f.a.s. CK-MB, Continued

Substantial equivalence (continued)

Table 1, continued.

Feature	C.f.a.s(Modified Device)	C.f.a.s. K062319(Predicate Device)
Traceability	Traceability for each constituent isdescribed in the reagent systeminstructions for use.	Same
	Additional Reference Materials1. SRM 909b and SRM 956for Calcium2. SRM 929 and SRM 956for Magnesium3. SRM 914 and SRM 967for Creatinine Jaffe4. SRM 909b (IDMS) and SRM 967for Creatinine Plus5. SRM 909b (IDMS) and SRM 1951for Triglycerides GB	Reference Materials1. SRM 909bfor Calcium2. SRM 929for Magnesium3. SRM 914for Creatinine Jaffe4. SRM 909b (IDMS)for Creatinine Plus5. SRM 909b (IDMS)for Triglycerides GB
	Reference Material Name Changes1. ERM DA470k for Albumin Plus2. Primary Reference Material - USPfor Salicylate	Reference Material Names1. CRM 470 for Albumin Plus2. Primary Reference Materialfor Salicylate
	Reference Method Publication Update1. IFCC (2002), Manual for ALT2. IFCC (2002), Manual for AST3. IFCC (2002), Manual for CK4. IFCC (2002), Manual for LD	Reference Method Publications1. IFCC (1985), Manual for ALT2. IFCC (1985), Manual for AST3. IFCC (1991), Manual for CK4. IFCC (1994), Manual for LD
ValueAssignment	Values to new lots are assigned byrunning them as samples aftercalibrating the system with apreviously assigned C.f.a.s. lot.Values are verified by using referencematerial, Master lot C.f.a.s., andpreviously assigned lots of C.f.a.s.	Same
SourceMaterial	Human recombinant yGTHuman recombinant AST	Porcine kidney yGTPorcine heart AST

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510(k) Summary – Calibrator for Automated Systems (C.f.a.s.) and C.f.a.s. CK-MB, Continued

Table 2: Comparison of C.f.a.s. CK-MB
Feature	C.f.a.s. CK-MB(Modified Device)	C.f.a.s. CK-MB K003158(Predicate Device)
Intended Use	C.f.a.s. (Calibrator for automatedsystems) CK-MB is for use in thecalibration of Roche methods for thequantitative determination of CK-MBon Roche clinical chemistry analyzersas specified in the value sheets.	C.f.a.s. (Calibrator for automatedsystems) CK-MB is for use in thecalibration of Roche methods for thequantitative determination of CK-MBon automated clinical chemistryanalyzers.
Format	Lyophilized	Same
Stability	Lyophilized calibrator• 2 to 8 °C until expiration date	Lyophilized calibrator• same
	Reconstituted calibrator• 15 to 25 °C for 24 hours• 2 to 8 °C for 2 days• -15 to -25 °C for 4 weeks (whenfrozen once)	Reconstituted calibrator• 15 to 25 °C for 24 hours• 2 to 8 °C for 2 days• -20 °C for 1 month (when frozenonce)
Levels	Single level	Same
ReagentComposition	Lyophilized calibrator based onbovine scrum albumin with chemicaladditives and material of biologicalorigin.	Same
Traceability	Traceability for each constituent isdescribed in the reagent systeminstructions for use.	Same
ValueAssignment	Values to new lots are assigned byrunning them as samples aftercalibrating the system with apreviously assigned C.f.a.s. CK-MBlot. Values are verified by usingreference material, Master lot C.f.a.sCK-MB, and previously assigned lotsof C.f.a.s. CK-MB.	Same
Sourcematerial	• Human recombinant CK-MB• Human CK-MM	• Porcine brain CK-BB• Human CK-MM

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510(k) Summary - Calibrator for Automated Systems (C.f.a.s.) and C.f.a.s. CK-MB, Continued

Constituents Tables 3 and 4 catalog the constituent analytes and their biological . source for both the modified and predicate devices. Table 3 summarizes C.f.a.s., a multi-analyte calibrator. For the modified C.f.a.s., the source material changes for two analytes, AST and yGT.

Table 3: Constituents of C.f.a.s.
	C.f.a.s(Modified Device)	C.f.a.s. K062319(Predicate Device)
Analyte	Source	Analyte	Source
ALT/ALAT	Porcine heart	ALT/ALAT	Same
AST/ASAT	Human, recombinant	AST/ASAT	Porcineheart
Albumin	Bovine plasma	Albumin	Same
Alkalinephosphatase	Human placenta (recombinant)	Alkalinephosphatase	Same
Amylase, total	Porcine pancreas	Amylase, total	Same
Amylase, pancreatic	Porcine pancreas	Amylase, pancreatic	Same
Bilirubin, direct	Endogenous and/or chemical additive	Bilirubin, direct	Same
Bilirubin, total	Endogenous and/or chemical additive	Bilirubin, total	Same
Calcium	Endogenous and/or chemical additive	Calcium	Same
Cholesterol	Bovine plasma	Cholesterol	Same
Cholinesterase	Human serum	Cholinesterase	Same
Creatine kinase	Rabbit muscle	Creatine kinase	Same
Creatinine	Endogenous and/or chemical additive	Creatinine	Same
yGT	Human, recombinant	yGT	Porcinekidney
Glucose	Endogenous and/or chemical additive	Glucose	Same
Iron	Endogenous and/or chemical additive	Iron	Same
Lactate	Endogenous and/or chemical additive	Lactate	Same
LD (LDH)	Porcine heart	LD (LDH)	Same
Lipase	Human pancreas (recombinant)	Lipase	Same
Lithium	Chemical additive	N/A1
Magnesium	Endogenous and/or chemical additive	Magnesium	Same
Phosphorus	Endogenous and/or chemical additive	Phosphorus	Same
Salicylate	Chemical additive	Salicylate	Same
Total Protein	Endogenous and/or chemical additive	Total Protein	Same
Triglycerides	Chicken egg yolk	Triglycerides	Same
UIBC	Endogenous and/or chemical additive	UIBC	Same
Urea/BUN	Endogenous and/or chemical additive	Urea	Same
Uric Acid	Endogenous and/or chemical additive	Uric Acid	Same

1 C.f.a.s. was cleared as the calibrator in the Lithium test system in K063684. The source for lithium is the same.

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510(k) Summary – Calibrator for Automated Systems (C.f.a.s.) and C.f.a.s. CK-MB, Continued

Table 4 summarizes C.f.a.s CK-MB. It is a single analyte calibrator Constituents (continued) that contains two Creatine kinase Isoenzyme sources; CK-MB Isoenzyme is the detected analyte in the test system. For the modified C.f.a.s. CK-MB, the source material changes for one of the two CK Isoenzyme biological additives.

Table 4: Constituents of C.f.a.s. CK-MB

C.f.a.s. CK-MB(Modified Device)		C.f.a.s. CK-MB K003158(Predicate Device)
Analyte	Source	Analyte	Source
CK-MBIsoenzyme	• Human recombinant CK-MBIsoenzyme• Human CK-MM Isoenzyme	CK-MBIsoenzyme	• Porcine brain CK-BBIsoenzyme• Human CK-MM Isoenzyme

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Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Re:

Food & Drug Administration 903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

Roche Diagnostics c/o Susan Hollandbeck Regulatory Affairs Consultant 9115 Hague Road, P.O. Box 50416 Indianapolis, IN, 46250-0416

8 2010 SEP

K101456 Trade Names: Calibrator for automated systems (C.f.a.s.) Calibrator for automated systems CK-MB (C.f.a.s. CK-MB) Regulation Number: 21 CFR §862.1150 Regulation Name: Calibrator, Multi-Analyte Mixture and Calibrator, Secondary Regulatory Class: Class II Product Codes: JIX, JIT Dated: August 23. 2010 Received: August 24, 2010

Dear Mr. Hollandbeck:

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 class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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

{8}------------------------------------------------

Page 2 -

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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to .

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Signature

Courtney C. Harper, Ph.D. 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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Indications for Use Form

K101456
SEP 08 2010

510(k) Number (if known): k 101456

Device Name:

Calibrator for automated systems (C.f.a.s.)

Indications for Use:

Calibrator for automated systems (C.f.a.s) is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets.

Prescription Use メ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

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

Carlos

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K101456

Page 1 of 1

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Indications for Use Form

510(k) Number (if known): K101456

Device Name:

K101456

SEP 08 2010

Calibrator for automated systems (C.f.a.s.) CK-MB

Indications for Use:

Prescription Use メ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

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

Davis

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K101456

Page 1 of 1

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.