(187 days)
No
The description focuses on traditional laboratory methods and comparisons to existing, non-AI/ML devices. There is no mention of AI, ML, image processing, or training/test sets indicative of AI/ML development.
No
The device is described as a diagnostic tool for identifying streptococcal groups and does not mention treating or preventing diseases.
Yes
Explanation: The device description states its purpose is "for the identification of streptococcal groups A, B, C, F and G." This indicates that the device is used to detect the presence of specific streptococcal bacteria, which is a diagnostic function. The "Key Metrics" section further provides sensitivity for identifying these groups, reinforcing its diagnostic role.
No
The device description and performance studies indicate a laboratory test kit for identifying streptococcal groups, which typically involves reagents and physical components, not solely software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Device Description: It describes a product used for the "identification of streptococcal groups A, B, C, F and G." This is a diagnostic test performed outside of the body (in vitro) on biological samples to identify the presence of specific bacteria.
- Performance Studies: The description of performance studies comparing it to other "grouping kits" and reporting metrics like sensitivity and overall agreement are typical for IVD devices.
- Predicate and Reference Devices: The listing of predicate and reference devices, which are also described as "grouping kits," further confirms its nature as an IVD.
The lack of an explicit "Intended Use / Indications for Use" section is unusual, but the other information strongly indicates its function as an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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 data compiled from one clinical laboratory in the US, one in Canada and one in the UK.
| Strep Group/No. Tested | Unipath (Oxoid) Acid Extraction Sensitivity |
|---|---|
| Group A | 111/111 (100%) |
| Group B | 117/120 (98%) |
| Group C | 80/83 (96%) |
| Group F | 59/66 (89%) |
| Group G | 90/90 (100%) |
| Total | 457/470 (97%) |
At one site, upon initial testing, 3 negative reactions were observed for Group B. Discrepancies were related to insufficient number of colonies used. Discrepancies were resolved upon retest.
At one site, upon initial testing, 3 negative reactions were observed for Group C. Discrepancies were related to insufficient number of colonies used. Discrepancies were resolved upon retest.
At one site, upon initial testing, 7 negative reactions were observed for Group F. 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%.
Key Metrics
Sensitivity: Group A (100%), Group B (98%), Group C (96%), Group F (89%), Group G (100%), Total (97%)
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3740
Streptococcus spp. serological reagents.(a)
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 identifyStreptococcus spp. from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genusStreptococcus 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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
0
510k Submission K962296 Requested Revisions 11-24-96 STREPTOLEX-STAT™ UNIPATH LIMITED
DEC 1 6 1996
510K SUMMARY
Date: November 24, 1996
ﺳﮯ
ﺴﻴﺮ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠ
・・・・
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
Uninath. Oxoid Division 217 Colonade Rd. Nepean Ontario
Product:
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.
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.
1
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 K96296 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 | 117/1201 |
| (98%) | ||
| Group C | 83 | 80/832 |
| (96%) | ||
| Group F | 66 | 59/663 |
| (89%) | ||
| Group G | 90 | 90/90 |
| (100%) | ||
| Total | 470 | 457/470 |
| (97%) |
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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.
-
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.
-
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.