The Elecsys PreciControl Universal is a lyophilized product consisting of added antigens in a human serum matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels.

AI/ML Overview

The provided document is a 510(k) summary for the Elecsys PreciControl Universal. It describes a device modification to add Carcinoembryonic antigen (CEA) and total Prostate-Specific Antigen (PSA) controls. However, it does not contain explicit acceptance criteria or a detailed study section with performance data that directly addresses specific acceptance criteria for these newly added analytes or the overall device performance in a way that allows for a direct comparison table.

The document states: "The Elecsys PreciControl Universal was evaluated for value assignment and stability." This indicates that performance studies were conducted, but the results of these studies and any defined acceptance criteria are not explicitly presented within the provided text.

Therefore, many of the requested details cannot be extracted directly from this submission.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Acceptance Criteria: Not explicitly stated in the provided document.
Reported Device Performance: The document only mentions that the device "was evaluated for value assignment and stability." It does not provide specific performance data (e.g., accuracy, precision, stability limits) for the added CEA and tPSA analytes, nor for the existing analytes in relation to specific acceptance criteria.

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

Sample Size: Not specified for any performance evaluation.
Data Provenance: Not specified.
Retrospective or Prospective: Not specified.

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)

The device is a quality control material. Ground truth in this context would likely refer to the reference values assigned to the control material. The document does not describe the process of establishing these reference values or refer to "experts" in the clinical sense (like radiologists). It only states that analytes "are spiked into the matrix at the desired concentration levels" and that "value assignment" was evaluated.

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

Not applicable as the nature of the "test set" and "adjudication" in the context of clinical interpretation is not relevant for this type of quality control device. The document mentions "value assignment," which implies a process for determining the target concentrations.

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 device is a quality control material for immunoassays, not a diagnostic imaging AI tool or a device that involves human interpretation of results requiring MRMC studies.

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

This is a quality control material. Its "performance" is in its ability to consistently produce expected values when measured by an immunoassay analyzer. It does not involve an algorithm generating a diagnostic output to be evaluated as "standalone." The evaluation of "value assignment and stability" would be akin to a standalone performance evaluation for this type of device.

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

For a quality control material, the "ground truth" is the assigned reference value for each analyte. The document indicates analytes are "spiked into the matrix at the desired concentration levels" and that "value assignment" was evaluated. The specific methodology for establishing these assigned values (e.g., using reference methods, internal standards, or consensus from multiple measurements) is not detailed.

8. The sample size for the training set

This is a quality control material for immunoassay analyzers. It does not involve machine learning or a "training set" in the typical sense.

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

Not applicable, as there is no "training set" for this type of device.

Summary of what is known:

The Elecsys PreciControl Universal is a lyophilized control product with added antigens in a human serum matrix. It is used for quality control of Elecsys immunoassays on Elecsys and cobas e immunoassay analyzers. The current submission is a modification to add Carcinoembryonic antigen (CEA) and total Prostate-Specific Antigen (PSA) controls. Evaluation was performed for "value assignment and stability." The predicate device is the Elecsys PreciControl Universal (K051687).

Summary

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JUL - 2 2009

Elecsys PreciControl Universal

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K090541/

510(k) Summary – PreciControl Universal

Introduction	According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence.
Submittername, address,contact	Roche Diagnostics9115 Hague RoadIndianapolis, IN 46250317-521-3723Contact Person: Gail SauersDate Prepared: February 27, 2009
Submissionpurpose	Roche Diagnostics hereby submits this Traditional 510(k) devicemodification to provide notification of changes to our control material,Elecsys PreciControl Universal (PCU).PreciControl Universal is used for quality control of Elecsys immunoassayson the Elecsys and cobas e immunoassay analyzers. This product containscontrol material for numerous Elecsys assays in one convenient solution.Changes to PCU consist of the addition of Carcinoembryonic antigen (CEA)control and total (free + complexed) Prostate-Specific Antigen (PSA) toextend the current functionality.
Device Name	Proprietary name: Elecsys PreciControl Universal.Common name: PreciControl UniversalClassification name: Multi-Analyte Controls, All Kinds (assayed andUnassayed)
DeviceDescription	The Elecsys PreciControl Universal is a lyophilized product consisting ofadded antigens in a human serum matrix. During manufacture, the analytesare spiked into the matrix at the desired concentration levels.
Intended use	Elecsys PreciControl Universal is used for quality control of Elecsysimmunoassays on the Elecsys and cobas e immunoassay analyzers.
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PredicateDevice	The Elecsys PreciControl Universal is substantially equivalent to thecurrently marketed Elecsys PreciControl Universal (PCU) K051687.
DeviceComparison	The table below indicates the similarities between the modified ElecsysPreciControl Universal and the predicate PCU, K051687.

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510(k) Summary – continued

Similarities

Characteristics	Elecsys PreciControl Universal	Predicate DeviceElecsys PreciControl Multianalyte(K051687)
Intended Use	Elecsys PreciControl Universal is used forquality control of Elecsysimmunoassays on theElecsys and cobas eimmunoassay analyzers	Elecsys PreciControlUniversal is used forquality control of theElecsys immunoassayson Elecsys immunoassaysystems.
Reagent Format	Same	Lyophilized, based onhuman serum in twoconcentration ranges.
Matrix	Same	Human serum matrix
Stability	Same	Unopened:Store at 2-8°C untilexpiration dateReconstituted (exceptfor Insulin):• on the analyzers at 20-25 °C: up to 5 hrs• At 2-8°C: 3 days• At -20°C: 1 month(freeze only once)Reconstituted forInsulin:• on the analyzers at 20-25 °C: up to 5 hrs• 20-25 °C: up to 5 hrs• at -20: 1 month (freezeonly once)

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510(k) Summary - continued

continued	Characteristics	Elecsys PreciControlUniversal	Predicate DeviceElecsys PreciControlMultianalyte(K051687)
	Handling	Same	Reconstitute withexactly 3.0 mL ofdistilled water and allowto stand closed for 30minutes to reconstitute,and then mix gently.
Performance		The Elecsys PreciControl Universal was evaluated for value assignment and
	stability.
		The table below indicates the differences between the modified ElecsysPreciControl Universal and the predicate PCU, K051687.
CharacteristicsDeviceComparisonDifferences	Characteristics	Elecsys PreciControlUniversal	Predicate DeviceElecsys PreciControlMultianalvte(K051687)
Differences -continued	Characteristics	Elecsys PreciControlUniversal	Predicate Device ElecsysPreciControlMultianalyte(K051687)
AnalyteConcentration	• AFP (human cell culture) approx. 10-50 IU/ml	• AFP (human cell culture) approx. 10-50 IU/ml
	• Cortisol (vegetable) approx. 359-500 nmol/L	• B12 (synthetic) approx. 1-.5 ng/mL
	• DHEAs (synthetic) approx. 200-500 µg/dL	• Cortisol (vegetable) approx. 13-30 µg/dL
	• Estradiol (synthetic) approx. 100-500 pg/mL	• DHEAs (synthetic) approx. 200-500 µg/dL
	• FSH (human) approx. 10-45 mIU/mL	• Estradiol (synthetic) approx. 100-500 pg/mL
	• fT3 (synthetic) approx. 6-25 pmol/L	• Ferritin (human) approx. 150-30 ng/mL
	• fT4 (synthetic) approx. 12-35 pmol/L	• Folate (synthetic) approx. 12-5.5 ng/mL
	• hCG (human) approx. 5-40 mIU/mL	• FSH (human) approx. 10-45 mU/mL
	• IgE (human) approx. 70-300 U/mL	• fT3 (synthetic) approx. 4-16 pg/mL
	• Insulin, (human, recomb.) approx. 25-80 μU/mL	• fT4 (synthetic) approx. .9-2.7 ng/dL
	• LH (human) approx. 9-50 mIU/mL	• hCG (human) approx. 10-40 mU/mL
	• Progesterone (vegetable) approx. 8-20 ng/mL	• IgE (human) approx. 70-300 U/mL
	• Prolactin (human recombinant) approx. 233-848 µIU/mL	• Insulin, (human, recomb.) approx. 25-80 μU/mL
	• SHBG (human) endogenous	• LH (human) approx. 9-50 mU/mL
	• T3 (synthetic) approx. 2-6 nmol/mL	• Progesterone (vegetable) approx. 8-20 ng/mL
	• T4 (synthetic) approx. 90-170 nmol/L	• Prolactin (human recombinant) approx. 11-40 ng/mL
	• Testosterone (vegetable) approx. 6-2.5 ng/mL	• SHBG (human) endogenous
	• Thyroglobulin * (human) approx. 25-100 ng/mL	• T3 (synthetic) approx. 1.5-4 ng/mL
	• TSH (human) approx. 1-8.5 µIU/mL• T-Uptake approx. (human) 1-.75 TBI• CEA (human cell culture) approx. 5-50 ng/mL• tPSA (human) approx. 1-40 ng/mL• S100 * (bovine) approx. .2-2.5 ng/mL* not included in US labeling	• T4 (synthetic) approx. 7-13 µg/dL• Testosterone (vegetable) approx. 6-2.5 ng/mL• TSH (human) 1-8.5 µU/mL• T-Uptake (human) 1.1-.75 TBI

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510(k) Summary - continued

Roche

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Elecsys PreciControl Universal

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: . . . . . .

the state of the state of the states and s

。 . .

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Roche Diagnostics ATTN: Ms. Gail Sauers Regulatory Affairs Consultant 9115 Hague Road Indianapolis, IN 46250-0416

JUL - 2 2009

K090541 Re:

Trade/Device Name: Elecsys PreciControl Universal Regulation Number: 21 CFR §862,1660 Regulation Name: Quality control material (assayed and unassayed). Regulatory Class: Class I (Reserved) Product Code: JJY Dated: May 27, 2009 Received: June 02, 2009

Dear Ms. Sauers:

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); 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 (OS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Courtney C. Harper, Ph.D. 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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Indication for Use

510(k) Number (if known):

Device Name: Elecsys PreciControl Universal

Indication For Use:

Elecsys PreciControl Universal is used for quality control of Elecsys immunoassays on Elecsys and cobas e immunoassay analyzers.

Prescription Use _ X (21 CFR Part 801 Subpart D) . And/Or

Over the Counter Use _ (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Division Sign-Off

notir

Office of In Vitro Diagnostic Device Evaluation and Safety

Evaluation and Safety:
510(k) K096541

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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.