DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL

K972904 · Casco Standards · JJY · Feb 20, 1998 · Clinical Chemistry

Device Facts

• Record ID: K972904
• Device Name: DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL
• Applicant: Casco Standards
• Product Code: JJY · Clinical Chemistry
• Decision Date: Feb 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

This product is intended for use as an unassayed control material on the Abbott LCx Probe System with the Abbott Chlamydia Amplification Kit in the qualitative determination of Chlamydia trachomatis. This product is intended to serve as an unassayed control material to monitor the analytical precision of the LCR amplification system incorporated in the Abbott LCx Probe System used in conjunction with the Abbott Chlamydia Amplification Kit. Response ratios (S/CO) have been set at appropriate positive (+) and negative (-) levels. This product is intended for in vitro use only.

Device Story

Device consists of positive and negative control materials in stabilized biological matrix; packaged in 2 mL plastic screw-cap bottles. Used in clinical laboratory settings by laboratory technicians to monitor analytical precision of Abbott LCx Probe System during Chlamydia trachomatis testing. Device provides known positive and negative samples to validate analytical run validity. Healthcare providers use output (S/CO ratio) to ensure assay performance; helps verify accuracy of patient test results; benefits patients by ensuring reliable diagnostic testing for Chlamydia trachomatis.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Liquid control material in stabilized biological matrix. Two levels (positive and negative). 2 mL volume. Compatible with Abbott LCx Probe System. No specific materials of construction or software algorithms described; device is a chemical control reagent.

Indications for Use

Indicated for in vitro use as an unassayed control material to monitor analytical precision of the Abbott LCx Probe System LCR amplification system when used with the Abbott Chlamydia Amplification Kit for qualitative determination of Chlamydia trachomatis.

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

• Abbott LCx Chlamydia Negative Control

Submission Summary (Full Text)

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. FEB 20 1998

510(k) Summary

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### FEDERAL FOOD, DRUG AND COSMETIC ACT 510(k) SUMMARY DOCUMENT MÓLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL

- 1. Submitted by: CASCO Standards P.O. Box 970 Yarmouth, ME 04096
- Christine V. Beach Attention: Manager, Regulatory Affairs

[phone] [phone] FAX

February 11,1998 (revision to June 27, 1997 submission)

### 2. Product Name:

DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS Proprietary Name: CONTROL

Classification Name: Control, single analyte, unassayed.

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# 3. Predicate Device:

# Negative:

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Abbott LCx Chlamydia Negative Control

# Positive

Urine, Human, Positive for Chlamydia trachomatis, as recommended in the package insert for the Abbott Chlamydia Amplification Kit.

The DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA 4. Product Description: TRACHOMATIS Control is composed of plastic screw cap bottles, 2 mL each, containing two (2) levels of control, positive and negative, for Chlamydia trachomatis in a stabilized biological matrix. The formulation design provides a liquid matrix that is compatible with the Abbott Chlamydia Amplification Kit for assay on the LCx Probe System for the direct, qualitative determination of Chlamydia trachomatis.

- 5. Intended Use: This product is intended for use with the Abbott Chlamydia Amplification Kit in the Abbott LCx Probe System for the direct, qualitative determination of Chlamydia trachomatis.

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# 6. Comparison to the Predicate Device:

| Characteristic | DOCUMENT<br>MOLECULAR<br>PATHOLOGY<br>CHLAMYDIA<br>TRACHOMATIS<br>Negative Control | Abbott LCx<br>Chlamydia<br>Negative Control | DOCUMENT<br>MOLECULAR<br>PATHOLOGY<br>CHLAMYDIA<br>TRACHOMATIS<br>Positive Control | Urine, Human<br>Chlamydia<br>trachomatis<br>Positive |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Intended Use | Unassayed control<br>intended for use<br>with the Abbott<br>Chlamydia<br>Amplification Kit in<br>the Abbott LCx<br>Probe System for the<br>direct, qualitative<br>determination of<br>Chlamydia<br>trachomatis | Automatically<br>assessed by LCx,<br>in conjunction with<br>the calibrator, to<br>determine the<br>validity of the<br>analytical run | Unassayed control<br>intended for use<br>with the Abbott<br>Chlamydia<br>Amplification Kit in<br>the Abbott LCx<br>Probe System for<br>the direct, qualitative<br>determination of<br>Chlamydia<br>trachomatis | N/A |
| Number of Levels | One (1) | One (1) | One (1) | N/A |
| Type | Negative | Negative | Positive | Positive |
| Analytes | 1 | 1 | 1 | N/A |
| Instrument Output | Rate | Rate | Rate | Rate |
| Measurement | S/CO Ratio | Instrument Pre-set | S/CO Ratio | S/CO Ratio |
| Volume | 2 mL | 0.48 ml | 2 mL | N/A |
| Matrix | Stabilized biological<br>matrix | Buffered solution | Stabilized biological<br>matrix | N/A |
| Dilution | None required | Activation | None required | None required |
| Unopened Stability | Until Expiration Date<br>12 Months | Until Expiration<br>Date | Until Expiration Date<br>12 Months | N/A |
| Open Stability | 30 Days | 48 hrs. post-<br>activation | 30 Days | N/A |

Image /page/2/Picture/6 description: The image is completely white and contains no discernible content. There are no objects, shapes, or patterns visible. The image appears to be a blank canvas.

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Image /page/3/Picture/12 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 2 0 1998

Christine V. Beach Manager, QA/RA CASCO Standards P.O. Box 970 Yarmouth, Maine 04096-1970

K972904 Re : R772901 Trachomatis Control Regulatory Class: I Product Codes: JJY 75, LSK 83 Dated: December 2, 1997 Received: December 5, 1997

Dear Ms. Beach:

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 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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. ৰ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through ---periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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 requlations.

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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 Autman

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 : K972904

#### DOCUMENT® MOLECULAR PATHOLOGY CHLAMYDIA Device Name: TRACHOMATIS Control

Indications for Use:

This product is intended for use as an unassayed control material on the Abbott LCx Probe System with the Abbott Chlamydia Amplification Kit in the qualitative determination of Chlamydia trachomatis.

This product is intended to serve as an unassayed control material to monitor the analytical precision of the LCR amplification system incorporated in the Abbott LCx Probe System used in conjunction with the Abbott Chlamydia Amplification Kit. Response ratios (S/CO) have been set at appropriate positive (+) and negative (-) levels. -- ------

This product is intended for in vitro use only.

#### (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)