LYPHOCHEK ASSAYED CHEMISTRY CONTROL

K040273 · Bio-Rad Laboratories, Inc. · JJY · Mar 4, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040273
• Device Name: LYPHOCHEK ASSAYED CHEMISTRY CONTROL
• Applicant: Bio-Rad Laboratories, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Mar 4, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Lyphochek Assayed Chemistry Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Device Story

Lyphochek Assayed Chemistry Control is a human serum-based quality control product used in clinical laboratories to monitor the precision of testing procedures. It contains purified biochemicals, tissue extracts, chemicals, therapeutic drugs, preservatives, and stabilizers. The product is provided in lyophilized form at two levels. Laboratory personnel use the control to verify the performance of analytical assays. By comparing observed results against the lot-specific mean values provided in the package insert, clinicians and laboratory technicians assess the stability and accuracy of their testing systems, ensuring reliable diagnostic results for patients.

Clinical Evidence

No clinical data. Stability studies were performed to validate shelf life (3 years + 4 months at 2-8°C) and open-vial stability (7 days at 2-8°C, with 3-day exception for Acid Phosphatase/Prostatic Acid Phosphatase; 30 days at -10 to -20°C, with 20-day exception for Tobramycin).

Technological Characteristics

Lyophilized human serum matrix containing purified biochemicals, chemicals, therapeutic drugs, preservatives, and stabilizers. Storage at 2-8°C. Analyte-specific assay values provided for laboratory monitoring.

Indications for Use

Indicated for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for specific analytes in clinical chemistry settings.

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

• Lyphochek Assayed Chemistry Control (k874280)

Submission Summary (Full Text)

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## MAR - 4 2004

Summary of Safety and Effectiveness Lyphochek Assayed Chemistry Control

040273

#### 1.0 Submitter

Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 [phone] Telephone: [phone] Fax:

### Contact Person

Maria Zeballos Regulatory Affairs Specialist Telephone: [phone]

### Date of Summary Preparation

January 23, 2004

#### 2.0 Device Identification

| Product Trade Name: | Lyphochek Assayed Chemistry Control | |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Quality Control Materials, all kinds (Assayed and Unassayed) | |
| Characteristics | Bio-Rad<br>Lyphochek Assayed Chemistry Control<br>(New Device) | Bio-Rad<br>Lyphochek Assayed Chemistry Control<br>(Predicate Device K874280) |
| | Similarities | |
| Intended Use | Lyphochek Assayed Chemistry Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. | Lyphochek Assayed Chemistry Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. |
| Form | Lyophilized | Lyophilized |
| Matrix | Serum | Serum |
| Storage<br>(Unopened) | 2-8°C until expiration date | 2-8°C until expiration date |
| After Reconstitution<br>and Freezing | All analytes will be stable for 30 days when stored tightly capped at -10 to -20°C with the following exceptions: Tobramycin will be stable for 20 days | All analytes will be stable for 30 days when stored tightly capped at -10 to -20°C with the following exceptions: Tobramycin will be stable for 20 days |
| | Differences | |
| Open Vial | 7 days at 2 to 8°C with the following exceptions: Acid Phosphatase and Prostatic Acid Phosphatase will be stable for 3 days. | 7 days at 2 to 8°C with the following exceptions: Acid Phosphatase, Prostatic Acid Phosphatase and Alkaline Phosphatase will be stable for 3 days. |
| Analytes | Same as the predicate device with the following exceptions:<br>Does not contain claims for:<br>· Aldolase and Folate<br>Contains claims for the following additional analytes:<br>· Calcium (Ionized)<br>· Copper<br>· Glutamate Dehydrogenase (GLDH)<br>· Globulin<br>· Cholesterol (LDL)<br>· Iron-Binding Capacity, Total (TIBC)<br>· Iron Binding Capacity, Unsaturated (UIBC)<br>· T3 Free<br>· T4 Free<br>· Transferrin<br>· Vitamin B12<br>· Zinc | Acetaminophen<br>Acid Phosphatase, Total<br>Alanine Aminotransferase (ALT)<br>Albumin<br>Aldolace<br>Alkaline Phosphatase (ALP)<br>$\alpha$ HBDH<br>Alpha-1-Antitrypsin<br>Alpha-Fetoprotein (AFP)<br>Amylase<br>Amylase, Alpha<br>Amylase, Pancreatic<br>Apolipoprotein A-1<br>Apolipoprotein B<br>Aspartate Aminotransferase (AST/SGOT)<br>Bilirubin, Direct<br>Bilirubin, Indirect<br>Bilirubin, Total<br>C3 Complement<br>C4 Complement<br>Calcium<br>Carbamazepine<br>Carbon Dioxide (CO2)<br>Carcinoembryonic Antigen (CEA)<br>Ceruloplasmin<br>Chloride<br>Cholesterol, High Density Lipoprotein (HDL)<br>Cholesterol, Total<br>Cholinesterase<br>Cortisol<br>Creatine Kinase (CK)<br>Creatinine<br>Digoxin<br>Folate<br>Gamma Glutamyltransferase (GGT)<br>Gentamicin<br>Glucose<br>Haptoglobin<br>Immunoglobulin A (IgA)<br>Immunoglobulin G (IgG)<br>Immunoglobulin M (IgM)<br>Iron<br>Lactate (Lactic Acid)<br>Lactate Dehydrogenase (LDH)<br>LAP - Arylamidase<br>Lipase<br>Lithium<br>Magnesium<br>Osmolality<br>Phenobarbital<br>Phenytoin<br>Phosphorus<br>Potassium<br>Prostate Specific Antigen (PSA)<br>Prostatic Acid Phosphatase (PAP)<br>Protein Electrophoresis<br>Protein, Total<br>Salicylate<br>Sodium<br>T3 Total<br>T3 Uptake<br>T4 Total<br>Theophylline<br>Thyroid Stimulating Hormone (TSH)<br>Thyroxine Binding Globulin (TBG)<br>Tobramycin<br>Transferrin<br>Triglycerides<br>Urea<br>Urea Nitrogen<br>Uric Acid<br>Valproic Acid |

Class I Classifications: JJY Product Code: CFR 862.1660 Regulation Number:

#### Device to Which Substantial Equivalence is Claimed 3.0

Lyphochek Assayed Chemistry Control Bio-Rad Laboratories Irvine, California

Docket Number: K87'4280

#### 4.0 Description of Device

Lyphochek Assayed Chemistry Control is prepared from human serum with added constituents of purified biochemicals (tissue extracts of human and animal origin), chemicals, therapeutic drugs, preservatives and stabilizers. The control is provided in lyophilized form.

#### 5.0 Statement of Intended Use

Lyphochek Assayed Chemistry Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

#### Comparison of the new device with the Predicate Device 6.0

Lyphochek Assayed Chemistry Control claims substantial equivalence to the Lyphochek Assayed Chemistry Control currently in commercial distribution (K874280).

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# Table 1. Similarities and Differences between new and predicate device.

#### Statement of Supporting Data 7.0

Stability studies have been performed to determine the open vial stability and shelf life for the Lyphochek Assayed Chemistry Control. Product claims are as follows:

- Open vial: All analytes will be stable for 7 days at 2 to 8°C with the following exceptions: 7.1 Open vial Acid Prostatic Acid Phosphatase will be stable for 3 days.

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- After reconstitution and freezing: All analytes will be stable for 30 days when stored at -7.2 ARCH Foodnetication of Tobramycin which will be stable for 20 days.
- Shelf Life: 3 Years + 4 Months at 2 to 8°C 7.3
- Real time studies will be ongoing to support the shelf life of this product. 7 4

All supporting data is retained on file at Bio-Rad Laboratories.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR - 4 2004

Ms. Elizabeth Platt Regulatory Affairs Manager/Quality Assurance Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, CA 92618-2017

k040273 Re:

Trade/Device Name: Lypochek Assayed Chemistry Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: January 23, 2004 Reccived: February 5, 2004

Dear Ms. Platt:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have cletermined the device is substantially equivalent (for the indications for use stated in the enclosurc) 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, ate 1606 that 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 I ou mays arouvisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adultcration.

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 or any I 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 his lotter will and in your e FDA finding of substantial equivalence of your device to a legally prematicated 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, rr you decire on the promotion and advertising of your device, 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" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou the) of Small Manufacturers, International 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 vours.

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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510 (k) Number (if known): _K040273

Lyphochek Assayed Chemistry Control Device Name:

Indications for Use:

For use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

(PLEASE DO NOT WRITE BELOW THE LINE-CONINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use or

Over-the Counter use

Carol C. Benson
Division Sign-Off

Office of In Vitro Dlagnostic Office Evaluation and Safety

510(k) K040273