PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA

K993360 · Roche Diagnostics Corp. · JJY · Nov 24, 1999 · Clinical Chemistry

Device Facts

• Record ID: K993360
• Device Name: PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA
• Applicant: Roche Diagnostics Corp.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Nov 24, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Roche Diagnostics Precinorm® Universal Plus and Precipath® Universal Plus Control Sera is intended for quality control in the quantitative determination of substrates, electrolytes, lipids, enzymes, proteins, and drugs. The control is used for monitoring accuracy or precision for manual techniques and assays from Roche on automated clinical chemistry analyzers.

Device Story

Precinorm® Universal Plus and Precipath® Universal Plus Control Sera are lyophilized human serum-based quality control products; used to monitor accuracy and precision of clinical chemistry assays. Device provides two levels of control (normal and pathological) containing specific constituent analytes. Used by laboratory personnel in clinical settings to validate performance of manual techniques and automated chemistry analyzers. Healthcare providers use control results to verify assay reliability before reporting patient test results; ensuring diagnostic accuracy. Modification from predicate includes addition of specific analyte values (e.g., Albumin, Lithium, Digoxin) and improved stability profile for reconstituted product.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Lyophilized pooled human serum; two-level control product. Reconstituted stability: 5 days at 2-8 °C, 12 hours at 25 °C, 1 month at -20 °C. Analyte values include substrates, electrolytes, lipids, enzymes, proteins, and drugs.

Indications for Use

Indicated for quality control in the quantitative determination of substrates, electrolytes, lipids, enzymes, proteins, and drugs in clinical laboratory settings using manual or automated chemistry analyzers.

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

• Roche Diagnostics Precinorm® Universal and Precipath® Universal Control Sera (K811832)

Submission Summary (Full Text)

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NOV 2 4 1999

K993360

# 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 provides sufficient detail to understand the basis for a determination of substantial equivalence. |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter name, address, contact | Roche Diagnostics Corporation<br>9115 Hague Rd<br>Indianapolis IN 46250<br>[phone]<br><br>Contact person: Priscilla A. Hamill<br><br>Date prepared: October 4, 1999 |
| Predicate device | Roche Diagnostics Precinorm® Universal Plus and Precipath® Universal Plus Control Sera is substantially equivalent to other devices legally marketed in the United States. We claim equivalence to the currently marketed Roche Diagnostics Precinorm® Universal and Precipath® Universal Control Sera (K811832) |
| Device description | Roche Diagnostics Precinorm® Universal Plus and Precipath® Universal Plus Control Sera is a two level quality control product prepared from lyophilized human serum with addition of constituent analytes as required to obtain normal and pathological levels. |

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### 510(k)*Summary – Precinorm® Universal and Precipath® Universal Plus Control Sera, continued

| Intended use /<br>Indication for<br>use | Roche Diagnostics Precinorm® Universal Plus and Precipath® Universal<br>Plus Control Sera is intended for quality control in the quantitative<br>determination of substrates, electrolytes, lipids, enzymes, proteins, and drugs.<br>The control is used for monitoring accuracy or precision for manual<br>techniques and assays from Roche on automated clinical chemistry analyzers. |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial<br>equivalence | The most important modification of the device presented in this submission is<br>the inclusion of values for additional analytes. Similarities and differences<br>are presented in detail below. |
| Substantial<br>equivalence -<br>similarities | The following table compares Precinorm® Universal Plus and Precipath®<br>Universal Plus Human Serum Controls, with the predicate device (currently<br>marketed modified Precinorm® Universal and Precipath® Universal Human<br>Serum Controls.) |

| Characteristic | Precinorm® Universal Plus<br>and Precipath® Universal<br>Plus Control Sera<br>(Modified Device) | Precinorm® Universal and<br>Precipath® Universal<br>Human Serum Controls<br>(Predicate Device) |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For quality control in the<br>quantitative determination of<br>substrates, electrolytes, lipids,<br>enzymes, proteins, and drugs.<br>The control is used for<br>monitoring accuracy or<br>precision for manual<br>techniques and assays from<br>Roche on automated clinical<br>chemistry analyzers. | For control of chemistry<br>assays. This control material<br>is well suited for both manual<br>and automated analytical<br>procedures. |
| Format | Lyophilized pooled human<br>sera with constituents added<br>as required to obtain desired<br>component levels | Lyophilized pooled human<br>serum with constituents added<br>as required to obtain desired<br>component levels |
| Levels | Two levels | Two levels |

#### Comparison of Modified Device and Predicate Device

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## 510(k) Summary – Precinorm® Universal and Precipath® Universal Plus Control Sera, continued

| Characteristic | Precinorm® Universal<br>Plus and Precipath®<br>Universal Plus Control<br>Sera<br>(Modified Device) | Precinorm® Universal<br>and Precipath® Universal<br>Human Serum Controls<br>(Predicate Device) |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Stability | Stable at 2-8 °C until expiration date Reconstituted:<br>✓ 2-8 °C - 5 days<br>✓ 25° - 12 hrs<br>✓ -20° - 1 month, with<br>exceptions as noted in | Stable at 2-8 °C until expiration date Reconstituted:<br>✓ 2-8 °C - 2 days<br>✓ 10-24° - 8 hrs<br>✓ -20° - 1 month, with<br>exceptions as noted in |

labeling

The new device includes values for additional analytes listed in the table below.

| Additional analytes. | |
|----------------------|-----------------------------------|
| Albumin | Lithium |
| Bicarbonate | Magnesium |
| Gamma globulins | Salicylate |
| Copper | Total iron binding capacity |
| Digoxin | Thyroxine (T4) |
| GLDH | T-Uptake |
| Arylamidase | Unsaturated iron-binding capacity |

Substantial equivalence -differences addition of constitutent analyte values

28

labeling

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three abstract shapes that resemble human profiles or flowing lines. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

#### Nov 24 1999

Ms. Priscilla A. Hamill Regulatory Affairs, Laboratory Systems Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457

K993360 Re:

> Trade Name: Precinorm® Universal Plus and Precipath® Universal Plus Control Sera Regulatory Class: I Product Code: JJY Dated: October 4, 1999 Received: October 6, 1999

Dear Ms. Hamill:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### INDICATIONS FOR USE STATEMENT

510(k) Number (if known): NHA K 993360

Device Name: Precinorm® Universal Plus and Precipath® Universal Plus Control Sera

Indications For Use:

For quality control in the quantitative determination of substrates, electrolytes, lipids, enzymes, proteins, and drugs. The control is used for monitoring accuracy or precision both for manual techniques and assays from Roche on automated clinical chemistry analyzers.

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| | Concurrence of CDRH, Office of Device Evaluation (ODE) | | | |
|------------------------------------------|--------------------------------------------------------|----|--|----------------------|
| Prescription Use<br>(Per 21 CFR 801.109) | | OR | | Over-The-Counter Use |

2-96)

Rita E. Makin

(Division Sign-Off)
Division of Clinical Laboratory Devices

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