RPR LIQUID CONTROLS

K955143 · Remel, L.P. · GMP · Jul 30, 1996 · Microbiology

Device Facts

• Record ID: K955143
• Device Name: RPR LIQUID CONTROLS
• Applicant: Remel, L.P.
• Product Code: GMP · Microbiology
• Decision Date: Jul 30, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3820
• Device Class: Class 2

Device Story

RPR Liquid Controls are in vitro diagnostic reagents used to monitor the performance of RPR card tests. The controls consist of positive and negative samples used by laboratory personnel to verify the accuracy and reliability of the RPR assay procedure. By comparing the results obtained with the REMEL controls against expected outcomes, clinicians ensure the test system is functioning correctly before reporting patient results. This quality assurance process helps maintain the integrity of diagnostic testing for syphilis, ensuring that patient results are accurate and reliable.

Clinical Evidence

Bench testing only. Comparative performance data collected at multiple clinical sites (Mich. Dept. PH, UTex) over several months. REMEL positive and negative controls were tested alongside reference controls (Difco). Results showed consistent agreement in qualitative reactivity (Reactive/Non-Reactive) and reactivity strength (e.g., 4+/mR) across all dates and sites.

Technological Characteristics

In vitro diagnostic liquid reagents. Formulated as positive and negative controls for RPR card agglutination assays. Standalone reagents; no electronic or software components.

Indications for Use

Indicated for use as quality control reagents for RPR (Rapid Plasma Reagin) card tests to monitor the performance of the assay.

Regulatory Classification

Identification

Treponema pallidum nontreponemal test reagents are devices that consist of antigens derived from nontreponemal sources (sources not directly associated with treponemal organisms) and control sera (standardized sera with which test results are compared) used in serological tests to identify reagin, an antibody-like agent, which is produced from the reaction of treponema microorganisms with body tissues. The identification aids in the diagnosis of syphilis caused by microorganisms belonging to the genus Treponema and provides epidemiological information on syphilis.

Reference Devices

• Difco RPR Card Test Controls

Submission Summary (Full Text)

{0}

K955143

JUL 30 1996

Food and Drug Administration
Center for Devices and Radiological Health
Document Mail Center (HFZ-401)
9200 Corporate Blvd.
Rockville, MD 20850

RE: 510(k) Submission for RPR
Liquid Controls Summary
of Safety and
Effectiveness

November 8, 1995

Dear Sir:

In accordance with 21 CFR Chapter 1, Subpart E, Sec. 807.93, and as part of the 510(k) submission for the RPR Liquid Controls, the following information is provided.

Reasonable assurance that this device is safe and effective was determined through the use of valid scientific nonclinical investigations including in vitro studies. The results of these studies are summarized in the attached Technical Insert.

This device is effective when tested under the conditions for its intended use. Each test kit contains a technical insert which provides adequate directions and precautions for use. Lastly, each insert contains information on the limitations and the performance characteristics of the test (including relative sensitivity and specificity data) when used according to the directions.

SUMMARY OF SAFETY AND EFFECTIVENESS DATA:

Raw performance data
Intended use of the product
Limitations of the product
Relative sensitivity and specificity data
Directions for procedure
510(k) Submission

Should there be any questions concerning this matter, please contact me at [phone].

Sincerely,

David A. Wall
Manager, Immunodiagnostics

5

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| REMEL RPR CARD TEST CONTROLS Comparative Data | | | | | | Site: Mich. Dept.PH | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | R | Bomfom | MofH 6346 R.W | bom67-95 | MofH 6346 - | PI: H. Bilefol | |
| Date | REMEL Pos Ctrl | Reference Pos Ctrl | REMEL Neg Ctrl | Reference Neg Ctrl | | | |
| 7-10-95 | R | Rmed | R W | N | - | | |
| 7-11-95 | R | Rmed | R W | N | - | | |
| 7-14-95 | R | Rmed | R W | N | - | | |
| 7-21-95 | R | Rmed | R W | N | - | | |
| 7-21-95 | R | Rmed | R W | N | - | | |
| 7-27-95 | R | Rmed | R W | N | - | | |
| 7-31-95 | R | Rmed | R W | N | - | | |
| 8-3-95 | R | Rmed | R W | N | - | | |
| 8-8-95 | R | Rmed | R W | N | - | | |
| 8-12-95 | R | Rmed | R W | N | - | | |
| 8-17-95 | R | Rmed | R W | N | - | | |
| 8-18-95 | R | Rmed | R W | N | - | | |
| 8-21-95 | R | Rmed | R W | N | - | | |
| 8-22-95 | R | Rmed | R W | N | - | | |
| 8-23-95 | R | Rmed | R W | N | - | | |
| 8-25-95 | R | Rmed | R W | N | - | | |
| 8-28-95 | R | Rmed | R W | N | - | | |
| 8-29-95 | R | Rmed | R W | N | - | | |
| 8-30-95 | R | Rmed | R W | N | - | | |
| 9-1-95 | R | Rmed | R W | N | - | | |
| 9-5-95 | R | Rmed | R W | N | - | | |
| 9-6-95 | R | Rmed | R W | N | - | | |
| 9-7-95 | R | Rmed | R W | N | - | | |
| 10-27-95 | R=3005 | Rmed | R W | N | - | | |
| 10-31-95 | R | Rmed | | N | | | |

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9821-964-904 X03

1

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site - UTex.
PI: Hartwell

| REMEL RPR CARD TEST CONTROLS Comparative Data | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | Difco | | Difco | | | |
| Date | REMEL Pos Ctrl | Reference Pos Ctrl | REMEL Neg Ctrl | Reference Neg Ctrl | | | |
| | R (4+)/mr (3+) | R (4+)/mr (4+) | NR | NR | | | |
| 7/3/95 | R / mr (3+) | R / mr (3+) | NR | NR | | | |
| | | | | | | | |
| 7/5/95 | R / mr | R / mr | NR | NR | | | |
| | | | | | | | |
| 7/6/95 | R / mr | R / mr | NR | NR | | | |
| | | | | | | | |
| 7/2/95 | R / mr | R / mr | NR | NR | | | |
| | | | | | | | |
| 7/21/95 | R / mr | R / mr | NR | NR | | | |
| | | | | | | | |
| 7/24/95 | R / mr | R / mr | NR | NR | | | |
| | | | | | | | |
| 7/25/95 | R / mr | R / mr | NR | NR | | | |
| | | | | | | | |
| 7/24/95 | R / mr | R / mr | NR | NR | | | |
| | | | | | | | |
| 7/31/95 | R / mr | R / mr | NR | NR | | | |
| | | | | | | | |
| 8/1/95 | R / mr | R / mr | NR | NR | | | |
| | | | | | | | |
| 8/3/95 | R / mr | R / mr | NR | NR | | | |
| | | | | | | | |
| 8/4/95 | R / mr | R /mr | NR | NR | | | |
| | | | | | | | |

{3}

Site: VTex.
PI: Hartwell

| REMEL RPR CARD TEST CONTROLS Comparative Data | | | | | | Site: | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | Difco | | | | PH: | |
| Date | REMEL Pos Ctrl | Reference Pos Ctrl | REMEL Neg Ctrl | Reference Neg Ctrl | | | |
| | R4+ / mR | R4+ / mR | NR | NR | | | |
| 8/10/95 | R / mR | R / mR | NR | NR | | | |
| | | | | | | | |
| 8/14/95 | R / mR | R / mR | NR | NR | | | |
| | | | | | | | |
| 9/22/95 | R / mR | R / mR | NR | NR | | | |
| | | | | | | | |
| 9/22/95 | R mR | R mR | NR | NR | | | |
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