MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA

K042389 · Roche Diagnostics Corp. · JJY · Sep 14, 2004 · Clinical Chemistry

Device Facts

• Record ID: K042389
• Device Name: MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA
• Applicant: Roche Diagnostics Corp.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Sep 14, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Precinorm ® U Plus/ Precipath ® U Plus are for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet

Device Story

Precinorm U Plus and Precipath U Plus are lyophilized human serum-based quality control products. They contain added constituents adjusted to represent normal and pathological ranges for various analytes, including enzymes, proteins, and substrates. The device is used in clinical laboratories by laboratory technicians or clinicians to monitor the accuracy and precision of quantitative analytical methods, both manual and automated. By comparing measured values against the provided value sheet, users verify the performance of their clinical chemistry analyzers. This monitoring ensures the reliability of patient test results, aiding in accurate clinical decision-making.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Lyophilized human serum-based control. Contains biological additives including recombinant human lipase and bovine-derived albumin/protein (for Precinorm U Plus). Stability specifications defined for reconstituted serum at various temperatures (-25°C to 25°C).

Indications for Use

Indicated for use as a quality control material to monitor the accuracy and precision of quantitative laboratory methods for substrates, electrolytes, lipids, enzymes, proteins, and selected drugs in human serum samples.

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.

Submission Summary (Full Text)

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SEP 1 4 2004

#### 510(k) Summary - Precinorm ® Universal Plus and Precipath ® Universal Plus Control Sera

| Introduction | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Proprietary name: Roche Diagnostics Precinorm ® Universal Plus and<br>Precipath ® Universal Plus Control Sera (Precinorm® U Plus and Precipath<br>® U Plus) |
| | Common name : Control Sera |
| | Classification name: Multi-analyte controls, all kinds (assayed and<br>unassayed) |
| Device description | Precinorm ® U Plus/ Precipath ®U Plus is a quality control product<br>consisting of lyophilized human sera with constituents added as required to<br>obtain desired component levels. Concentrations of control components have<br>been adjusted to represent normal and pathological ranges. |
| Intended use | Precinorm ® U Plus/ Precipath ® U Plus are for use in quality control by<br>monitoring accuracy and precision for the quantitative methods as specified in<br>the enclosed value sheet |
| | Continued on next page |

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# 510(k) Summary - Precinorm ® Universal and Precipath ® Universal Control Sera ,Continued

| Substantial<br>Equivalence | Roche claims substantial equivalence to the currently marketed Roche<br>Diagnostics Precinorm® U Plus/ Precipath ® U Plus (K993360). | | |
|------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Submitter<br>name, address,<br>contact | Roche Diagnostics<br>9115 Hague Road<br>Indianapolis, IN 46250<br>[phone] | | |
| | Contact person: Theresa M. Ambrose | | |
| | Date prepared: August 18, 2004 | | |
| Substantial<br>Equivalence –<br>Device<br>comparison | The table below compares Precinorm® U Plus/ Precipath ® U Plus with the<br>predicate device (currently marketed Precinorm® U Plus/ Precipath ® U<br>Plus). | | |

| Characteristic | Precinorm® U Plus/ Precipath ®<br>U Plus (Predicate device,<br>K993360) | Precinorm® U Plus/ Precipath ® U<br>Plus (Modified Device) |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For use in the quality control of<br>Roche methods for the quantitative<br>determination of substrates,<br>electrolytes, lipids, enzymes,<br>proteins, and selected drugs. The<br>control is used for monitoring<br>accuracy or precision both for<br>manual techniques and assays on<br>automated clinical chemistry<br>analyzers. | For use in quality control by<br>monitoring accuracy and precision for<br>the quantitative methods as specified in<br>the enclosed value sheet |
| Format | Lyophilized control serum based on<br>human serum. Concentrations of<br>control components have been<br>adjusted to represent normal and<br>pathological ranges. | Same |

Continued on next page

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## 510(k) Summary - Precinorm ® Universal and Precipath ® Universal Control Sera ,Continued

| | Substantial Equivalence - Device comparison (continued) | | |
|--|---------------------------------------------------------|--|--|
|--|---------------------------------------------------------|--|--|

| Characteristic | Precinorm® U Plus/ Precipath ®<br>U Plus (Predicate device,<br>K993660) | Precinorm® U Plus/ Precipath ® U<br>Plus (Modified Device) |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Stability | Unopened<br>Until expiration date at 2-8°C | Unopened<br>Same |
| | Opened/reconstituted:<br>12 hours at 25 °C<br>5 days at 4°C<br>1 month at -20°C when frozen once | Opened/reconstituted:<br>12 hours at 15-25°C<br>5 days at 2 to 8°C<br>4 weeks at -15 to -25 °C when frozen<br>once |
| | Bicarbonate in reconstituted serum<br>2 days in closed bottle<br>1 hour in open bottle<br><br>Bilirubin in reconstituted serum<br>(protected from light)<br>2 hours at 25 °C<br>1 day at 4°C<br>2 weeks at -20°C when frozen once | Bicarbonate in reconstituted serum<br>Same<br><br>Total bilirubin in reconstituted serum<br>(protected from light)<br>8 hours at 15-25°C<br>24 hours at 2 to 8°C<br>2 weeks at -15 to -25 °C when frozen<br>once<br><br>Direct bilirubin in reconstituted serum |
| | Inorganic phosphorus in<br>reconstituted serum (protected from<br>light)<br>5 hours at 25 °C<br>1 day at 4°C<br>1 month at -20°C when frozen once | (protected from light)<br>4 hours at 15-25°C<br>8 hours at 2 to 8°C<br>2 weeks at -15 to -25 °C when frozen<br>once |

Continued on next page

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### 510(k) Summary - Precinorm ® Universal and Precipath ® Universal Control Sera, Continued

| Characteristic | Precinorm® U Plus/ Precipath ®<br>U Plus (Predicate device,<br>K993360) | Precinorm® U Plus/ Precipath ® U<br>Plus (Modified Device) |
|---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Constituent<br>Analytes from<br>biological<br>additives | • ALT (GPT)<br>• AST (GOT)<br>• Albumin<br>• Aldolase<br>• Alkaline Phosphatase<br>• Amylase, total<br>• Amylase, pancreatic<br>• Cholesterol<br>• Cholinesterase<br>• Creatine kinase<br>• γ-GT<br>• GLDH<br>• LD (LDH)<br>• Lipase<br>• Acid phosphatase<br>• Total Protein | Same |
| Origin of<br>selected<br>biological<br>additives | • Lipase from porcine pancreas<br><br>• Albumin and total protein from<br>human serum | • Lipase from human pancreas<br>(recombinant)<br><br>• For Precinorm® U Plus: albumin<br>and total protein from bovine serum<br>• For Precipath ® U Plus: same |

#### Substantial Equivalence – Device comparison (continued)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms or branches extending upwards. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the left side of the logo.

SEP 1 4 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Theresa M. Ambrose, Ph.D. RAC Regulatory Affairs Principal Roche Diagnostics 9115 Hague Road PO Box 50457 Indianapolis, IN 46250-0457

k042389 Re:

K042367
Trade/Device Name: Precinorm® Universal Plus Precipath ® Universal Plus Control Sera Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: September 1, 2004 Received: September 2, 2004

Dear Dr. Ambrose:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Sector 710(x) premainted is substantially equivalent (for the indications referenced above and nave ucterinined the devices marketed in interstate for use stated in the enclosure) to regary manced produced Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Edical Federal Food. Drug commerce prior to May 28, 1970, the chacmises with the provisions of the Federal Food, Drug, devices that have been recults in accordance while as proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosmetic Act (Act) that ao not require approvate of the general controls provisions of the Act. The You may, therefore, market the device, subject to use gentration, listing of
general controls provisions of the Act include requirements for annual mistranding ond general controls provisions of the receiners required in the bronibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (sec above) into entrols. Existing major regulations affecting your device it may be subject to such additional confirent. Basing news 800 to 895. In addition, FDA
can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In can be lound in Title 21, Code of Pederal regulation in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA \$ issualles of a successful other requirements of the Act
that FDA has made a determination that your device complies with openaise - You must that FDA has made a delcrimiation that Jour averses by other Federal agencies. You must or any Federal statutes and regulations administered of registration and listing (21 comply with an the Act s requirements, moraling, and good manufacturing practice
CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice CFR Part 807), labeling (21 CFR Parts 60 Pailts (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter while and you to begin mailing of substantial equivalence of your device to a legally premailed notification: "The Pice is 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, If you destions on the promotion and advertising of your device, please contact the Office of of questions on the promotion and Safety at [phone]. Also, please note the In Pin o Diagiosao De Horanding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou thay ovant other general mormational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Jean M. Cooper, MS, DVM.

Jean M. Cooper, MS, D.V.M. 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: Precinorm ® Universal Plus and Precipath ® Universal Plus Control Sera

Indications For Use:

Precinorm ® U Plus is for use in quality control by monitoring accuracy and precision for the Frechnorin ® O Fras is ropecified in the enclosed value sheet.

quantitative menods as specifical in the control by monitoring accuracy and precision for the Frecipatii & O Fras is specified in the enclosed value sheet.

X Prescription Use (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)

Albert Sontz

Division Sign-Of

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Office of In Vitro Diagnostia Device Evaluation and Safety

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