PRECICONTROL CLINCHEM MULTI 1 AND 2

K102016 · Roche Diagnostics · JJY · Sep 1, 2010 · Clinical Chemistry

Device Facts

• Record ID: K102016
• Device Name: PRECICONTROL CLINCHEM MULTI 1 AND 2
• Applicant: Roche Diagnostics
• Product Code: JJY · Clinical Chemistry
• Decision Date: Sep 1, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

PreciControl ClinChem Multi 1 and 2 are for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets.

Device Story

PreciControl ClinChem Multi 1 and 2 are lyophilized human serum-based quality control products. They contain various analytes at normal and pathological concentrations, as specified in lot-specific value sheets. The device is used by laboratory professionals to monitor the accuracy and precision of quantitative clinical chemistry assays. By comparing measured values of the control against the assigned target values, clinicians assess the performance of their analytical systems. This monitoring helps ensure the reliability of patient test results, supporting clinical decision-making.

Clinical Evidence

No clinical data. Bench testing only. Stability studies (real-time and accelerated) confirmed shelf-life and open-vial stability. Value assignment performed via multi-analyzer calibration against master calibrators.

Technological Characteristics

Lyophilized human serum-based control. Contains various clinical chemistry analytes. Stability: Unopened stable at 2-8°C until expiration; reconstituted stability varies by analyte (12 hours at 15-25°C, 5 days at 2-8°C, 4 weeks at -15 to -25°C). Traceable to master lots/reference methods.

Indications for Use

Indicated for use as quality control material to monitor accuracy and precision of quantitative clinical chemistry methods on specified analyzers. Intended for prescription use only.

Regulatory Classification

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.

Predicate Devices

• Precinorm Universal Plus and Precipath Universal Plus (K042389)

Submission Summary (Full Text)

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K102016

# 510(k) Summary – PreciControl ClinChem Multi 1 and 2

| Introduction | Roche Diagnostics Corporation hereby submits this 510(k) to provide notification of our intent to market new controls named PreciControl ClinChem Multi 1 and 2. |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter name, address, contact | Roche Diagnostics<br>9115 Hague Rd.<br>PO Box 50416<br>Indianapolis, IN 46250<br>Phone: [phone]<br>Fax: [phone] |
| | Contact Person: Patrick Stimart |
| | Date prepared: July 16, 2010 |
| Device Name(s) | Proprietary name(s): 1. PreciControl ClinChem Multi 1 and 2 |
| | Common name(s): PCCC Multi 1 and 2 |
| | Classified under 21 CFR 862.1660 |
| | Classification name(s): Multi-analyte controls, all kinds (assayed and unassayed) |
| | Product Code: JJY |
| Device Description | The PreciControl ClinChem Multi 1 and 2 are quality control products consisting of lyophilized human sera with constituents added as required to obtain desired component levels. Concentrations of the components in the controls have been adjusted to represent normal and pathological levels. The concentrations of the components in the controls are lot-specific and representative values are given in the enclosed value sheets. |
| | Continued on next page |

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### 510(k) Summary – PreciControl ClinChem Multi 1 and 2, Continued .

PreciControl ClinChem Multi 1 and 2 are for use in quality control by Intended Use monitoring accuracy and precision for the quantitative methods as specified in the value sheets. and the comments of the comments of the comments of the comments of the comments of the comments of the contribution of the contribution of the contribution of the contributi Roche claims substantial equivalence to the Roche Diagnostics Predicate Precinorm Universal Plus and Precipath Universal Plus (K042389). Device

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## 510(k) Summary -- PreciControl ClinChem Multi 1 and 2, Continued

The following table compares the PreciControl ClinChem Multi 1 and Substantial equivalence -2 controls with the predicate device. similarities

| Characteristic | PreciControl ClinChem<br>Multi 1 and 2 controls | Precinorm U plus and Precipath<br>U plus controls (K042389) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | PreciControl ClinChem Multi 1<br>and 2 are for use in quality<br>control by monitoring accuracy<br>and precision for the quantitative.<br>methods as specified in the value<br>sheets. | Precinorm U plus and Precipath U<br>plus are for use in quality control<br>by monitoring accuracy and<br>precision for the quantitative<br>methods as specified in the value<br>sheets. |
| Format | PreciControl ClinChem Multi 1<br>and 2 are lyophilized controls<br>based on human serum. The<br>adjusted concentrations and<br>activities of the control<br>components are in the normal and<br>pathological ranges. | Precinorm U plus and Precipath U<br>plus are lyophilized controls based<br>on human serum. The adjusted<br>concentrations and activities of the<br>control components are usually in<br>the normal and pathological ranges. |
| Stability | • Same<br>• Same | • Unopened: Stable at 2-8°C<br>until expiration date.<br>• Stability of components<br>after reconstitution*:<br>at 15-25 °C 12 hours<br>at 2-8 °C 5 days<br>at (-15)-(-25) °C 4 weeks<br>(when frozen once) |
| | *Exceptions stated for total<br>bilirubin, direct bilirubin, UIBC,<br>and ALT | *Exceptions stated for total<br>bilirubin, direct bilirubin and<br>Bicarbonate |
| Traceability | Same | Traceability of the target values is<br>given in the respective instructions<br>for use of the system reagents. |
| Value<br>Assignment | Same | Traceable through Master Lot to<br>standards or reference methods. |
| Constituent Analytes | | |
| PreciControl ClinChem<br>Multi 1 and 2 controls | Precinorm U plus and<br>Precipath U plus controls (K042389) | |
| Same | Alanine aminotransferase, Albumin,<br>Alkaline phosphatase, Amylase, Amylase<br>pancreatic, Aspartate aminotransferase,<br>Bilirubin direct, Bilirubin total, Calcium,<br>Chloride, Cholesterol, Cholinesterase,<br>Creatine kinase, Creatinine, Glucose,<br>gamma Glutamyltransferase, Iron,<br>Lactate, Lactate dehydrogenase, Lipase,<br>Lithium, Magnesium, Phosphate,<br>Potassium, Sodium, Total protein,<br>Triglycerides, Unsaturated iron -binding<br>capacity, Urea, Uric acid | |
| Not included | Acid phosphatase, Aldolase, Bicarbonate,<br>Copper, Digoxin, Glutamate<br>dehydrogenase, alpha Hydroxybutyrate<br>dehydrogenase, Leucine aminopeptidase,<br>Phospholipids, Thyroxine, T-uptake | |
| alpha 1 Acid glycoprotein, Antisteptolysin<br>O, alpha 1 Antitrypsin, Apolipoprotein A-<br>1, Apolipoprotein B, C Reactive protein,<br>Ceruloplasmin, Complement C3c,<br>Complement C4, Creatine kinase MB,<br>HDL-Cholesterol, Haptoglobin,<br>Immunoglobulin A, Immunoglobulin G,<br>Immunoglobulin M, LDL-Cholesterol,<br>Prealbumin, Transferrin, Ferritin | Not included | |

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# 510(k) Summary – PreciControl ClinChem Multi 1 and 2, Continued

The following table compares the PreciControl ClinChem Multi 1 and Substantial 2 controls with the predicate device. equivalence differences

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle head with three stripes representing the agency's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

Public Health Service

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

Roche Diagnostics Corp. c/o Mr. Patrick J. Stimart Regulatory Affairs Consultant 9115 Hague Road, PO Box 50416 Indianapolis, IN 46250-0416

1 2010 SEP

k102016 Re:

> Trade Name: Precicontrol Clinichem Multi 1 and 2 Regulation Number: 21 CFR §862.1660 Regulation Name: Quality control material (assayed and unassayed). Regulatory Class: Class I, reserved Product Codes: JJY Dated: July 16, 2010 Received: July 19, 2010

Dear Mr. Stimart:

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, provisions facturing 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 (1 will), it thay be bacyce be found in Title 21, Code of Federal Regulations (CFR), Parts affecting your at 1100 on, 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 r lease be advised thas made a determination that your device complies with other not mount that I Driver any Federal statutes and regulations administered by other requirements of the Precess of the Act's requirements, including, but not I cocharagenetes: 1 od may sing (21 CFR Part 807); labeling (21 CFR Parts 801 and 11med to: registration and nisting (1 medical device-related adverse events) (21 807), incureal device reporting (reporting (requirements as set forth in the quality systems (QS) 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 [phone]. 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 [phone]. 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 [phone] or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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

KID2016

510(k) Number (if known):

Device Name: PreciControl ClinChem Multi 1 and 2

Indications for Use:

PreciControl ClinChem Multi 1 and 2 are for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets.

Prescription Use __ X ________________________________________________________________________________________________________________________________________________________

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

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

Signature: Steve Dillon

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

510(k) 14/02/16

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