CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013

K022725 · Good Biotech Corp. · JJX · Sep 23, 2002 · Clinical Chemistry

Device Facts

• Record ID: K022725
• Device Name: CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013
• Applicant: Good Biotech Corp.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Sep 23, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Good Biotech Corp. CRPex CRP Controls are intended to be used as the assayed quality control material for serum C-reactive protein (CRP) analysis. For In Vitro Diagnostic Use.

Device Story

CRPex CRP Controls are liquid human serum-based quality control materials; used in clinical laboratories to monitor the precision and accuracy of C-reactive protein (CRP) assay systems. The controls contain specific levels of human serum CRP (Levels L, M, and H). Healthcare providers or laboratory technicians use these controls to validate the performance of their diagnostic equipment; ensuring that the assay system provides reliable results for the detection and evaluation of infection, tissue injury, and inflammatory disorders. The device does not perform analysis itself but serves as a reference standard to verify the operational integrity of the clinical testing process.

Clinical Evidence

No clinical data. The device is an in vitro diagnostic quality control material; substantial equivalence is based on bench testing comparing the matrix, biological source, and assigned concentration ranges to the predicate device.

Technological Characteristics

Liquid human serum-based control material. Provided in three levels (L, M, H) with assigned CRP concentration ranges. Intended for in vitro diagnostic use. No electronic, mechanical, or software components.

Indications for Use

Indicated for use as an assayed quality control material for serum C-reactive protein (CRP) analysis to monitor the precision and accuracy of assay systems in clinical 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

• Roche CRP T Control N (K982087)

Submission Summary (Full Text)

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SEP 2 3 2002

K022725

# 510(k) Summary Safety and Effectiveness

"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."

| | CRPex CRP Controls Level L, M, H |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Submitter | |
| Name, | Good Biotech Corp. |
| Address, | 38 34th Rd. Taichung Industrial Park Taichung City 407 Taiwan<br>R.O.C. |
| Telephone number, | [phone] |
| Contact person, | Victor Chiou |
| Preparation date | August 14, 2002 |
| Device | |
| Trade name, | CRPex CRP Controls Level L, M, H |
| Common name, | CRP Control Material |
| Classification name | C-reactive protein immunological test system (21CFR 866.5270) |
| Predicate Device | |
| Trade name, | Roche CRP T Control N |
| 510(k) number | K982087 |
| Description | |
| Good Biotech Corp. CRPex CRP Controls are intended to be used as the assayed quality control material for serum C-reactive protein (CRP) analysis. Each CRP Control contains certain level of human serum CRP to assist in monitoring the precision and accuracy of assay | |

systems within the clinical range.

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Measurement of C-reactive protein is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.

#### Intended Use

Good Biotech Corp. CRPex CRP Controls are intended to be used as the assayed quality control material for serum C-reactive protein (CRP) analysis. For in vitro diagnostic use.

### Substantial

Equivalence

CRPex-HS CRP Controls and Roche CRP T Control N are both human serum based controls with assigned C-reactive protein concentration and intended for use in monitoring accuracy and precision in CRP analysis.

| Item\Device | CRPex CRP Controls | Roche CRP T Control N |
|-------------------------------|--------------------------|-----------------------|
| Matrix/Biological Sources | Liquid human serum | Liquid human serum |
| Concentration Range<br>(mg/L) | Level L<br>1.28 – 1.92 | |
| | Level M<br>4.54 – 6.81 | 3.44 – 4.66 |
| | Level H<br>46.82 – 70.23 | |

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 2 3 2002

Mr. Victor Chiou President Good Biotech Corporation 38 34th Road Taichung Industrial Park 407 Taichung City, Taiwan, R.O.C.

k022725 Re:

> Trade/Device Name: CRPex CRP Controls Level L, M, H Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed). Regulatory Class: Class I Product Code: JJX Dated: August 14, 2002 Received: August 16, 2002

Dear Mr. Chiou:

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, 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 (PMA), 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 898. 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 v 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrlvdsma/dsmamain.html".

Sincerely yours,

Steven Butman

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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## STATEMENT OF INDICATIONS FOR USE

## 510(k) Number (if known): K 033-725__

Device Name: CRPex CRP Controls Level L, M, H

Indications For Use:

Good Biotech Corp. CRPex CRP Controls are intended to be used as the assayed quality control material for serum C-reactive protein (CRP) analysis. For In Vitro Diagnostic Use.

(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)

ાર

Over-The-Counter Use __

(Optional Format 1-2-96)

J.P. Reeves Acting Branch Chief I/

of Clinical Laboratory I 510(k) Number -