HICHEM TOTAL PROTEIN REAGENT

K992846 · Elan Holdings, Inc. · CEK · Oct 18, 1999 · Clinical Chemistry

Device Facts

• Record ID: K992846
• Device Name: HICHEM TOTAL PROTEIN REAGENT
• Applicant: Elan Holdings, Inc.
• Product Code: CEK · Clinical Chemistry
• Decision Date: Oct 18, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1635
• Device Class: Class 2

Intended Use

HiChem® Total Protein Reagent is intended for the quantitative determination of total protein in serum and plasma on the SYNCHRON CX® Systems and serum, plasma and cerebrospinal fluid on the SYNCHRON CX® DELTA Systems. Total protein results are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders. This reagent is intended for professional use only.

Device Story

In vitro diagnostic reagent kit for quantitative total protein measurement; utilizes serum, plasma, or cerebrospinal fluid samples. Designed for use on SYNCHRON CX® and SYNCHRON CX® DELTA Systems. Operated by laboratory professionals in clinical settings. Reagent facilitates biochemical analysis; results provided to clinicians to assist in diagnosing and monitoring liver, kidney, bone marrow, metabolic, and nutritional conditions. Benefits patient through objective biochemical data supporting clinical decision-making.

Clinical Evidence

Bench testing only. Precision studies (n=60 per sample) compared HiChem® vs. Beckman® reagents on SYNCHRON CX® DELTA System; calculated within-run and total imprecision (SD and %CV). Patient comparison study (n=160 serum/plasma, n=40 CSF) used least squares linear regression to compare HiChem® results against predicate; reported high correlation coefficients (r=0.988 and r=0.995 respectively).

Technological Characteristics

In vitro diagnostic chemical reagent for total protein quantification. Designed for automated clinical chemistry analyzers (SYNCHRON CX® series). Analytical principle based on standard biochemical assay methodology for protein determination. No software, electronics, or specific materials of construction (e.g., PEEK/titanium) described; device is a chemical reagent kit.

Indications for Use

Indicated for quantitative determination of total protein in serum, plasma, and cerebrospinal fluid in adult patients to aid in diagnosis and treatment of liver, kidney, bone marrow, metabolic, or nutritional disorders.

Regulatory Classification

Identification

A total protein test system is a device intended to measure total protein(s) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.

Predicate Devices

• SYNCHRON® CX® Systems Total Protein Reagent Kit (product no. 450224)

Submission Summary (Full Text)

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KG9284L

OCT 18 100 5

élan diagnostics

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Summary of 510(k) Safety and Effectiveness Information

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

HiChem® Total Protein Reagent is intended for the quantitative determination of total protein in serum and plasma on the SYNCHRON CX® Systems and serum, plasma and cerebrospinal fluid on the SYNCHRON CX® DELTA Systems. The HiChem® Total Protein Reagent Kit is substantially equivalent to the SYNCHRON® CX® Systems Total Protein Reagent Kit, product no. 450224, manufactured by Beckman Coulter, Inc.

The effectiveness of the Total Protein Reagent Kit is shown by the following studies.

## Precision:

Serum and cerebrospinal fluid controls were each assayed 3 times per 10 days using HiChem® and Beckman® total protein reagents on a SYNCHRON CX® DELTA System. Estimates of within run and total imprecision were calculated as described in NCCLS publication EP3-T.

Precision of Total Protein Recoveries

| Sample | unit | n | mean | HiChem® Reagent<br>Within Run | | | Total | | n | mean | Beckman® Reagent<br>Within Run | | | Total | |
|---------|-------|----|------|-------------------------------|-------|--|-------|-------|----|------|--------------------------------|------|--|-------|-------|
| | | | | 1SD | %CV | | 1SD | %CV | | | 1SD | %CV | | 1SD | %CV |
| Serum 1 | g/dL | 60 | 3.8 | 0.04 | 1.1% | | 0.06 | 1.7% | 60 | 3.8 | 0.04 | 1.2% | | 0.05 | 1.3% |
| Serum 2 | g/dL | 60 | 5.9 | 0.04 | 0.7% | | 0.08 | 1.3% | 60 | 5.9 | 0.04 | 0.8% | | 0.06 | 1.0% |
| Serum 3 | g/dL | 60 | 8.0 | 0.05 | 0.7% | | 0.11 | 1.4% | 60 | 8.0 | 0.05 | 0.6% | | 0.09 | 1.1% |
| CSF 1 | mg/dL | 60 | 21 | 3.17 | 15.2% | | 4.11 | 19.7% | 60 | 21 | 1.09 | 5.2% | | 2.58 | 12.2% |
| CSF 2 | mg/dL | 60 | 53 | 1.62 | 3.1% | | 2.31 | 4.4% | 60 | 54 | 1.52 | 2.8% | | 2.79 | 5.2% |

## Patient Comparison:

Serum, plasma and CSF specimens, collected from adult patients, were assayed using HiChem® and Beckman® total protein reagents on a SYNCHRON CX® DELTA System. Results were compared by least squares linear regression and the following statistics were obtained.

Serum/Plasma Comparison

HiChem® = 0.2 g/dL + 0.970 x Beckman® Reagent r = 0.988 n = 160 range = 4.6 - 8.6 g/dL CSF Comparison HiChem® = -2.8 mg/dL + 1.010 x Beckman® Reagent r = 0.995 n = 40 range = 11 - 332 mg/dL

Wynn Stocking

Wynn Stocking Manager of Regulatory Affairs Elan Diagnostics

20 August, 1999

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 1 8 1999

Mr. Wynn Stocking Manager, Regulatory Affairs Elan Diagnostics 231 North Puente Street Brea. California 92821

Re: K992846

> Trade Name: HiChem® Total Protein Reagent Regulatory Class: II Product Code: CEK Dated: August 20, 1999 Received: August 24, 1999

Dear Mr. Stocking:

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 reguirements 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 (OS) 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 [phone], or at its internet address "http://www.fda.gov/cdrl/dsma/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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510(k) Number (if known):

K992846

Device Name:

HiChem® Total Protein Reagent

Indications For Use:

HiChem® Total Protein Reagent is intended for the quantitative determination of total protein in serum and DRSma on the Hollen "Total Froten Frought formation of and cerebrospinal fluid on the SYNCHRON CX® DELTA Systems.
SYNCHRON CX® Systems and serum, plasma and cerebrospinal fluid on the SYN

Total protein results are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.

This reagent is intended for professional use only.

Respectfully,

Wyquin Stocking

Wynn Stocking Regulatory Affairs Manager Elan Diagnostics

20 August, 1999

Sean Cooper
(Division Sign-Off)

Division, Clinical Laboratory Devices
510(k) Number: K992846

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) √

OR

Over-The-Counter Use _

(Optional Format 1-2-96)

510(k) Notification, HiChem® Total Protein Reagent Elan Diagnostics, Brea; California