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K Number
K040708
Device Name
STATUS FIRST STREP A
Manufacturer
PRINCETON BIOMEDITECH CORP.
Date Cleared
2004-11-22

(249 days)

Product Code
GTY
Regulation Number
866.3740
Type
Traditional
Panel
MI
Reference & Predicate Devices
k971349
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Status First™ Strep A is an immunoassay for the qualitative detection of Group A Streptococcal antigen directly from throat swab specimens to aid in the early diagnosis of Group A Streptococcal infection.

Device Description

Status First"" Strep A is an in vitro, simple, one step immunochromatographic diagnostic test for the rapid, qualitative detection of Group A Streptococcal antigen

AI/ML Overview
  1. Acceptance Criteria and Reported Device Performance:

The provided 510(k) summary does not explicitly state numerical acceptance criteria for the Status First™ Strep A device. Instead, the device's performance is established through substantial equivalence to a legally marketed predicate device, BioSign StrepA (K971349).

Acceptance Criteria (Implied)Reported Device Performance
Substantially equivalent in intended use, principle, and performance to predicate device (BioSign StrepA, K971349)."The Status First™ Strep A test is substantially equivalent in intended use, principle and performance to the current BioSign Strep A test."
"The two products are identical and use the same manufacturing processes."Performance is considered identical to the predicate due to identical product and manufacturing processes, with only a minor difference in the sample extraction step described in the package insert.

  1. Sample Size for Test Set and Data Provenance:

    • Test Set Sample Size: Not specified. The document focuses on substantial equivalence based on product identity and manufacturing processes, rather than a new clinical performance study with a distinct test set.
    • Data Provenance: Not applicable for a new clinical performance study. The data provenance would be linked to the predicate device's original studies, which are not detailed here. The 510(k) refers to the predicate device BioSign StrepA, K971349.

  2. Number of Experts and Qualifications:

    • Not applicable. The submission focuses on substantial equivalence, not a new clinical study requiring expert ground truth establishment for a test set.

  3. Adjudication Method:

    • Not applicable. No new clinical performance study is described with a need for adjudication.

  4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

    • No MRMC comparative effectiveness study was done or reported in this 510(k) summary. The submission is for an in-vitro diagnostic device, which typically involves analytical performance studies and comparison to a predicate, not human reader performance studies.

  5. Standalone Performance:

    • Yes, in a way. The Status First™ Strep A is a standalone in-vitro diagnostic device. Its performance is implicitly the standalone performance as compared to the predicate device. However, a separate, new standalone performance study (i.e., with new data demonstrating accuracy, sensitivity, and specificity) is not detailed as part of this 510(k) submission. Its standalone performance is considered equivalent to the predicate.

  6. Type of Ground Truth Used:

    • Not explicitly stated for Status First™ Strep A in this document, as a new performance study wasn't described. For the predicate device, BioSign StrepA, it would typically involve culture methods as the "gold standard" for diagnosing Group A Streptococcal infection to establish true positive/negative results.

  7. Sample Size for Training Set:

    • Not applicable. This 510(k) does not describe an AI/machine learning device with a training set. It's an immunoassay.

  8. How Ground Truth for Training Set Was Established:

    • Not applicable, as there is no training set for this type of immunoassay device.

§ 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.