STREPTOLEX-STAT

K962296 · Unipath , Ltd. · GTZ · Dec 16, 1996 · Microbiology

Device Facts

• Record ID: K962296
• Device Name: STREPTOLEX-STAT
• Applicant: Unipath , Ltd.
• Product Code: GTZ · Microbiology
• Decision Date: Dec 16, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3740
• Device Class: Class 1

Indications for Use

STREPTOLEX-STAT™ is intended for the identification of streptococcal groups A, B, C, F and G from cultured organisms.

Device Story

STREPTOLEX-STAT™ is a latex agglutination test kit used for the identification of streptococcal Lancefield group antigens (A, B, C, F, G) from cultured bacterial samples. The device utilizes a nitrous acid extraction procedure to isolate antigens from the organisms. The test is performed in a clinical laboratory setting by trained laboratory personnel. The healthcare provider observes the presence or absence of agglutination to determine the specific streptococcal group. This qualitative result assists in the identification of streptococcal organisms, facilitating appropriate clinical management of patients with suspected streptococcal infections.

Clinical Evidence

Bench testing and clinical laboratory evaluation performed at three sites (US, Canada, UK) comparing STREPTOLEX-STAT™ to predicate grouping kits. Total sample size of 470 isolates. Overall sensitivity was 97% (457/470). Group-specific sensitivities: Group A (100%), Group B (98%), Group C (96%), Group F (89%), Group G (100%). Discrepancies were attributed to insufficient colony counts and resolved upon retesting.

Technological Characteristics

Latex agglutination assay; nitrous acid extraction reagents; qualitative visual readout; manual test procedure.

Indications for Use

Indicated for the qualitative identification of Lancefield groups A, B, C, F, and G streptococcal antigens from cultured organisms.

Regulatory Classification

Identification

Streptococcus spp. serological reagents are devices that consist of antigens and antisera (excluding streptococcal exoenzyme reagents made from enzymes secreted by streptococci) used in serological tests to identify Streptococcus spp. from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genus Streptococcus and provides epidemiological information on these diseases. Pathogenic streptococci are associated with infections, such as sore throat, impetigo (an infection characterized by small pustules on the skin), urinary tract infections, rheumatic fever, and kidney disease.

Predicate Devices

• Streptex and Streptex - Acid Extraction Kit (Murex Diagnostics, Inc.)
• PathoDx® Strep Grouping (Diagnostic Products Corporation)
• Streptococcal Grouping Kit (K854929) (Unipath Limited, Oxoid)

Submission Summary (Full Text)

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510k Submission K962296 Requested Revisions 11-24-96 STREPTOLEX-STAT™ UNIPATH LIMITED

DEC 16 1996

# 510K SUMMARY

Date: November 24, 1996

**Product Name:**
STREPTOLEX-STAT™

**Sponsor's Name:**
UNIPATH LIMITED
Wade Road
Basingstoke Hants
RG24 8PW England

**Product to be distributed in the US by:**

**Orion Diagnostica, Inc.**
71 Verconica Ave.
Somerset, NJ 008873

**Unipath, Oxoid Division**
217 Colonade Rd.
Nepean Ontario

## SUBSTANTIAL EQUIVALENCE

STREPTOLEX-STAT™ is substantially equivalent to several commercially available products utilizing similar methodology for the identification of streptococcal groups A, B, C, F and G.

Manufacturer: Murex Diagnostics, Inc.

Product: **Streptex** and **Streptex - Acid Extraction Kit** -
Provide an alternative method for the extraction and identification of Streptococcal Lancefield group antigens from cultured organisms.
This test offers a nitrous acid extraction procedure that is substantially equivalent to the STREPTOLEX-STAT™ procedure.

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# 510k Submission
K962296
Requested Revisions - 11-24-96
STREPTOLEX-STAT™
UNIPATH LIMITED

Manufacturer: Diagnostic Products Corporation

Product: PathoDx® Strep Grouping - a latex agglutination test designed to identify beta-hemolytic streptococci of Lancefield groups A, B, C, F, and G. This test offers a nitrous acid extraction procedure that is substantially equivalent to the STREPTOLEX-STAT™ procedure.

Manufacturer: Unipath Limited, Oxoid
Streptococcal Grouping Kit - A latex agglutination test for the identification of Streptococcal groups, A, B, C, D, F and G. This kit does not include a nitrous acid extraction method, but performance of the Unipath STREPTOLEX-STAT™ was compared to this substantially equivalent product for the qualitative grouping of streptococcal organisms. (K854929), and is currently being marketed by Unipath (Orion Diagnostica, Inc.)

{2}

510k Submission
K962296
Requested Revisions - 11-24-96
STREPTOLEX-STAT™
UNIPATH LIMITED

# PERFORMANCE DATA

The performance of the STREPTOLEX-STAT™ was compared to three commercially available, substantially equivalent grouping kits listed above. Studies were done at three test sites. The following is a summary of the performance data.

The data compiled from one clinical laboratory in the US, one in Canada and one in the UK. The following is a summary of the test results.

| Strep Group/No.
Tested | Unipath (Oxoid)
Acid Extraction
Sensitivity |
| --- | --- |
| Group A
111 | 111/111
(100%) |
| Group B
120 | 117/120^{1}
(98%) |
| Group C
83 | 80/83^{2}
(96%) |
| Group F
66 | 59/66^{3}
(89%) |
| Group G
90 | 90/90
(100%) |
| Total
470 | 457/470
(97%) |

1. At one site, upon initial testing, 3 negative reactions were observed. Discrepancies were related to insufficient number of colonies used. Discrepancies were resolved upon retest.

2. At one site, upon initial testing, 3 negative reactions were observed. Discrepancies were related to insufficient number of colonies used. Discrepancies were resolved upon retest.

3. At one site, upon initial testing, 7 negative reactions were observed. Discrepancies were related to insufficient number of colonies used. 5 of the 7 discrepancies were resolved upon retest.

Data comparing the STREPTOLEX-STAT™ Group Reagent with other commercially available grouping kits demonstrated an overall agreement of 97%.

These data clearly demonstrate the safety and efficacy and substantial equivalence of the STREPTOLEX - STAT™.

These data will be made available to any person within 30 days of a written request.

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