Important Note: The provided document is a 510(k) summary for a calibrator device. Regulatory summaries for calibrators typically focus on demonstrating substantial equivalence to a predicate, not on clinical performance or diagnostic accuracy studies in the same way an AI-powered diagnostic device would. Therefore, many of the requested fields related to clinical studies, human readers, and ground truth in a diagnostic context will not be applicable or explicitly stated.

Acceptance Criteria and Reported Device Performance

The provided document, K052002, is a 510(k) summary for a calibrator. For calibrators, "acceptance criteria" and "device performance" are typically related to their ability to accurately calibrate an assay, their stability, and their comparability to other calibrators. The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific quantitative performance metrics against predefined acceptance criteria for accuracy or clinical use.

No explicit quantitative acceptance criteria or detailed performance study results (e.g., sensitivity, specificity, accuracy) are provided in this 510(k) summary. The "study" here is primarily a substantial equivalence comparison.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (from document, if applicable)	Reported Device Performance (from document, if applicable)	Notes
Intended Use	Calibration for quantitative Unsaturated Iron Binding Capacity (UIBC) assays on Roche clinical chemistry analyzers.	Meets this intended use.	Stated in the "Indications for Use" and device description. No performance data beyond "intended use is met" for this.
Levels	Not explicitly stated as acceptance criteria, but characteristic is compared.	One level.	Differentiates from predicate (two levels), but implies this is acceptable for its intended purpose.
Format	Not explicitly stated as acceptance criteria, but characteristic is compared.	Aqueous solution.	Differentiates from predicate (lyophilized), but implies this is acceptable.
Handling	Not explicitly stated as acceptance criteria, but characteristic is compared.	Ready to use.	Differentiates from predicate (requires reconstitution), but implies this is acceptable.
Stability	Not explicitly stated as acceptance criteria, but characteristic is compared.	Unopened: 15-25°C until expiration date.After opening: 15-25°C until expiration date.	Differentiates from predicate (2-8°C unopened, -20°C reconstituted), but implies this is acceptable and verified.
Matrix	Not explicitly stated as acceptance criteria, but characteristic is compared.	Gravimetrically prepared aqueous solution of Ferrous Ammonium Sulfate Hexahydrate.	Compares composition. Implies this is an acceptable and verifiable matrix for a calibrator.
Substantial Equivalence	Demonstrated equivalence to predicate Elecsys® C-Peptide Calset (K033873).	Demonstrated through comparison of intended use, levels, format, handling, stability, and matrix, despite differences.	This is the primary "acceptance" for a 510(k) filing. The FDA's letter (K052002) confirms this determination.

The "study" that proves the device meets the acceptance criteria is the 510(k) submission itself, demonstrating substantial equivalence to a legally marketed predicate device. For a diagnostic calibrator, the primary "proof" is the demonstration that it performs its calibration function safely and effectively, and that it is substantially equivalent to existing calibrators on the market. Specific performance data related to its calibration efficacy (e.g., accuracy of calibrated assays) would typically be part of a larger assay's submission, not the calibrator's alone unless novel.

Additional Information Not Applicable or Directly Stated for This Device Type:

Most of the following items are highly relevant for diagnostic devices, especially those utilizing AI, and involve clinical effectiveness studies. As "Iron Standard" is a calibrator, these are generally not applicable and are not found in this 510(k) summary.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a calibrator, not a diagnostic device undergoing a clinical performance study with a test set of patient data.
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): Not applicable. Ground truth for a calibrator relates to its chemical properties and stability, not the interpretation of patient samples by experts.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 calibrator, not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a calibrator, "ground truth" would relate to the gravimetric preparation and analytical confirmation of the concentration of Ferrous Ammonium Sulfate Hexahydrate, and its stability characteristics. This is a chemical/analytical ground truth, not a clinical one. The document mentions "gravimetrically prepared aqueous solution," which indicates a highly controlled laboratory method for establishing the "truth" of its concentration.
The sample size for the training set: Not applicable. This is a calibrator; it does not involve machine learning or training sets in the computational sense.
How the ground truth for the training set was established: Not applicable.

Summary

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K052002

AUG 2 2 2005

510(k) Summary

Introduction	According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence
Submitter's name, address, and contact	Roche Diagnostics9115 Hague RoadIndianapolis, IN 46250317-521-3831
	Contact Person: Corina Harper
	Date Prepared: July 22, 2005
Device name	Proprietary name: Iron Standard
	Common name: Calibrator
	Classification name: Calibrator, Secondary, Class II
Predicate device	The Iron Standard is substantially equivalent to the currently marketed Elecsys® C-Peptide Calset (K033873).
Device description	The Iron Standard is a single-level product consisting of a gravimetrically prepared aqueous solution of Ferrous Ammonium Sulfate Hexahydrate.
Intended use	Iron Standard is for use in the calibration of quantitative Unsaturated Iron Binding Capacity (UIBC) assays on Roche clinical chemistry analyzers.
	Continued on next page

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510(k) Summary, Continued

Substantialequivalence:Similarities	The Iron Standard is substantially equivalent to the currently marketedElecsys® C-Peptide Calset (K033873). The below tables compare IronStandard with the predicate device, Elecsys® C-Peptide Calset.
---------------------------------------------	-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Characteristic	Iron Standard	Predicate DeviceElecsys® C-PeptideCalset (K033873)
Intended Use	For use in thecalibration ofquantitativeUnsaturated IronBinding Capacity(UIBC) assays onRoche clinicalchemistry analyzers.	For calibrating thequantitative Elecsys®C-Peptide assay on theElecsys® immunoassaysystems.
Levels	One	Two

Continued on next page

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510(k) Summary, Continued

Substantial equivalence: Differences

The below tables compare Iron Standard with the predicate device, Elecsys® C-Peptide Calset.

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Characteristic	Iron Standard	Predicate DeviceElecsys® C-PeptideCalset (K033873)
Format	Aqueous solution	Lyophilized
Handling	Ready to use	Add exactly 1.0 ml distilled water and allow to stand closed for 15 minutes to reconstitute. Mix carefully, avoiding the formation of foam.
Stability	Unopened:• Store at 15-25°C until expiration dateAfter opening:• 15-25°C: until expiration date	Unopened:• Store at 2-8°C until expiration dateReconstituted:• -20°C: 1 month (freeze only once)• On the analyzers at 20-25°C: use only once
	Matrix	Gravimetrically prepared aqueous solution of Ferrous Ammonium Sulfate Hexahydrate.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

DEPARTMENT OF HEALTH & HUMAN SERVICES USA

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 2 2 2005

Ms. Corina Harper, RAC Regulatory Affairs Consultant Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250

Re: K052002

Trade/Device Name: Iron Standard Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: July 22, 2005 Received: July 25, 2005

Dear Ms. Harper:

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) I mis letter mif anony you we 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, n you don't on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. 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/industry/support/index.html.

Sincerely yours,

Carol C. Benson

Carol C. Benson, M.A. Acting 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

510(k) Number (if known):

Device Name:

Iron Standard

Indications For Use:

Iron Standard is for use in the calibration of quantitative Unsaturated Iron Binding Capacity (UIBC) assays on Roche clinical chemistry analyzers.

Koszood

Prescription Use XXXX (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 IF NEEDED)

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

Division Sign-Off

Roche Diagnostics Confidential	Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)	K052002

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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.