(83 days)
Not Found
No
The device description details a chemical and optical reaction for antigen detection, with no mention of AI or ML technologies. The performance studies compare the device to traditional culture methods, not AI/ML-based analysis.
No
The device is an in vitro diagnostic (IVD) test used for rapid detection of Group B streptococcal antigen, not for treating a disease or condition.
Yes
The device is used for the rapid detection of group B streptococcal antigen, which is a diagnostic purpose to aid in medical decisions.
No
The device description clearly outlines a physical assay involving chemical reactions on an optical substrate and visual detection of color changes, indicating a hardware component is essential to its function.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the device is for the "rapid detection of group B streptococcal antigen directly from cervical and vaginal swabs from intrapartum maternity patients." This involves testing a sample taken from the human body to provide information about a physiological state (presence of Group B Streptococcus).
- Device Description: The description details a test that analyzes a biological sample (swab specimen) using a chemical and optical reaction to detect a specific analyte (group B streptococcal antigen). This is a hallmark of in vitro diagnostics.
- Sample Type: The device uses "cervical and vaginal swabs," which are biological specimens collected from the human body.
- Purpose: The purpose is to detect the presence of a specific pathogen (Group B Streptococcus) to aid in diagnosis and management of patients.
The information provided clearly aligns with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility of a potential recipient with a potential donor, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The BioStar® STREP B OLA® assay is an Optical ImmunoAssay (OTA) test for the rapid detection of group B streptococcal antigen directly from cervical and vaginal swabs from intrapartum maternity patients. The STREP B OIA assay is intended for use as an adjunct to culture, clinical observation and other information available to the physician.
Product codes
83GTY
Device Description
The STREP B OIA test involves the extraction of a carbohydrate antigen unique to group B Streptococi from the cervical or vaginal swab specimen and the subsequent use of Optical ImmunoAssay technology for the qualitative detection of this specific antigen. The Optical ImmunoAssay technology allows the direct visual detection of the physical change in optical thickness of molecular thing from the binding reactions between antibodies and antigens. The signal is generated by the reflection of light through the molecular thin films formed on an optical substrate. White light reflected through the molecular thin film results in a predominant visual background gold color. This color will not change unless the thickness of the optical molecular thin film is changed (Figure 1). When a liquid sample containing antigen from group B Streptococci is placed on the test surface, binding occurs between the antigen and immobilized antibody, causing an increased thickness in the molecular this reaction takes place, the optical path through the film is changed, causing a corresponding change in the gold color to purple/blue, thereby indicating a positive result. The change in optical thickness is due to the binding of specific antigen. If the antigen is not present in the sample, no binding takes place. The original molecular thickness remains unchanged and the test surface retains its original gold color, indicating a negative result. The clear endpoint and unequivocal results observed with the optical detection system lead to a very sensitive easily interpreted assay system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical and vaginal swabs
Indicated Patient Age Range
intrapartum maternity patients
Intended User / Care Setting
Physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The performance of the STREP B OIA assy was compared to that of routine microbiological Trypticase Soy Agar with 5% Sheep Blood (TSA) culture media and selective broth culture using Lim broth in a prospective evaluation of clinical specimens taken from women in the STREP B OLA test with Selective broth culture, cervical specimens were collected using standard techniques from 947 women using a dual swab (Duo-Transuber swabs-Medical Wire and Equipment Co., Spara, N). One swab was plated onto TSA within 24 hours of collection i im broth oversight. In addition, the pledget from the was placed in Lim broth, incubated and subcultured (10 ul) at 18-24 hours to a TSA plate. All plats were incubated in 5% C0 at 35-37°C. If beta-hemolytic streptococal colonies were selected and confirmed using a streptococal group serotyping method. The other swab was assayed in the STREP B OIA test within 24 hours of collection.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical testing, 947 samples comparing STREP B OIA to Lim Broth Culture.
Key results are detailed in the Key Metrics section below.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
COMPARISON of STREP B OIA to Lim Broth Culture 947 SAMPLES
Sensitivity = 63.8% CI (56.7-70.5%)
Specificity = 93.3% CI (91.3-95.0%)
COMPARISON of TSA Culture to Lim Broth Culture 947 SAMPLES
Sensitivity = 60.8% CI (53.7-67.6%)
Specificity = 99.6% CI (98.8-99.9%)
Culture Density vs. % OIA Positive
4+: 100% (31/31)
3+: 88 % (30/34)
2+: 83 % (15/18)
1+: 67 % (24/36)
Broth Only: 34 % (27/79)
Predicate Device(s)
Reference Device(s)
Not Found
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
8.0 510(k) SUMMARY (page 1 of 5)
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
A. Safety and effectiveness information required per {§807.92(a)(1){:
- SUBMITTER'S NAME: BioStar, Inc.
- ADDRESS: 6655 Lookout Rd. Boulder, CO 80301
- TELEPHONE: (303) 530-3888 ext. 603 .
- FAX: (303) 530-6601 .
- CONTACT PERSON: Roger C. Briden ●
- DATE 510(k) SUMMARY PREPARED: April 20, 1999 ●
B. Safety and effectiveness information required per [§807.92(a)(2)]:
- TRADE OR PROPRIETARY NAME: STREP B OIA®
- COMMON NAME: Group B Strep
- CLASSIFICATION NAME: Antigens, All Groups, Streptococcus spp
C. Identification of legally marketed device to which we are claiming equivalence {{807.92(a)(3)[:
- TRADE OR PROPRIETARY NAME: STREP B OIA® .
- REGULATORY CLASS: Class I .
- PRODUCT CODE: 83GTY .
- . MANUFACTURER: BioStar, Inc.
- 510(k) NUMBER: K936112 .
Note: Performance of the STREP B OIA product was established versus Lim broth as the reference standard.
D. Description of device [§807.92(a)(4)]:
Principle of the Test:
The STREP B OlA test involves the extraction of a carbohydrate antigen unique to group B Streptococi from the cervical or vaginal swab specimen and the subsequent use of Optical ImmunoAssay technology for the qualitative detection of this specific antigen. The Optical ImmunoAssay technology allows the direct visual detection of the physical change in optical thickness of molecular thing from the binding reactions between antibodies and antigens. The signal is generated by the reflection of light through the molecular thin films formed on an optical substrate.
1
510(k) SUMMARY (page 2 of 5)
White light reflected through the molecular thin film results in a predominant visual background gold color. This color will not change unless the thickness of the optical molecular thin film is changed (Figure 1). When a liquid sample containing antigen from group B Streptococci is placed on the test surface, binding occurs between the antigen and immobilized antibody, causing an increased thickness in the molecular this reaction takes place, the optical path through the film is changed, causing a corresponding change in the gold color to purple/blue, thereby indicating a positive result. The change in optical thickness is due to the binding of specific antigen. If the antigen is not present in the sample, no binding takes place. The original molecular thickness remains unchanged and the test surface retains its original gold color, indicating a negative result. The clear endpoint and unequivocal results observed with the optical detection system lead to a very sensitive easily interpreted assay system.
Device Components:
The STREP B OIA test kit contains the following:
Extraction Tubes Reagent 1A, extraction reagent Reagent 1B, extraction reagent Reagent 2, neutralization reagent Reagent 3, Conjugate Reagent 4, wash solution Reagent 5, Substrate - Test Devices Positive Control Transfer Pipettes Swabs
E. Intended use of device {§807.92(a)(5)]:
The BioStar® STREP B OIA® assay is an Optical ImmunoAssay (OIA) test for the rapid detection of group B streptococcal antigen directly from cervical and vaginal swabs from intrapartum maternity patients. The STREP B OIA assay is intended for use as an adjunct to culture, clinical observation and other information available to the physician.
2
Biostar Strep B OIA 510(k) May 28. 1999
510(k) SUMMARY (page 3 of 5)
F. Technological characteristics [§807.92(a)(6)]:
There are no changes. This is the same device used to establish performance versus TSA culture in K936112 and versus Lim broth in this submission.
| Technological Characteristic | Predicate Device (Strep B OIA®) | Our Device (STREP B OIA®) |
|---|---|---|
| Intended Use | The BioStar® Strep B OIA® assay is an | |
| Optical ImmunoAssay (OIA) test for the | ||
| rapid detection of Group B Streptococcal | ||
| antigen directly from cervical and vaginal | ||
| swabs from preterm and intrapartum | ||
| maternity patients. The Strep B OIA is | ||
| intended for use as an adjunct to culture, | ||
| clinical observation and information | ||
| available to the physician. | The BioStar® STREP B OIA® assay | |
| is an Optical ImmunoAssay (OIA) test | ||
| for the rapid detection of group B | ||
| streptococcal antigen directly from | ||
| cervical and vaginal swabs from | ||
| intrapartum maternity patients. The | ||
| STREP B OIA assay is intended for | ||
| use as an adjunct to culture, clinical | ||
| observation and other information | ||
| available to the physician. | ||
| Detection | Detects group B streptococcal antigen | Detects group B streptococcal antigen |
| Technology | OIA® Optical Immunoassay) | OIA® Optical Immunoassay) |
| Specimens Evaluated | Cervical / Vaginal swab | Cervical / Vaginal swab |
G. Summary of nonclinical testing [§807.92(b)(1)]:
- Only the clinical data has changed therefore the information provided here is what exists in the package insert ょ ………… for the cleared product.
" "Analytical Sensitivity:
LIMITS OF DETECTION
GBS cells of Subtypes Ia, Ib, II, III were grown on TSA / 5% sheep blood agar plates, harvested and diluted in saline. The diluted suspensions were enumerated by culture on TSA / 5% sheep blood agar plates. The following table presents the lowest concentration of each subtype giving a positive result in the assay.
| Subtype | Strain | OIA Sensitivity
(Cells / Assay) |
|---------|-------------|------------------------------------|
| Ia | CDC SS-880 | $1.6X10^4$ |
| Ib | CDC SS-884 | $1.4X10^4$ |
| Ic | CDC SS-1070 | $1.6X10^4$ |
| II | CDC SS-888 | $8.7X10^3$ |
| III | CDC SS-893 | $7.7X10^3$ |
3
Analytical Specificity (Cross Reactivity):
ANAL YTICAL SPECIFICITY (CROSS REACTIVITY)
To detectine the analytical specificity of the STREP B OIA test, the following organisms were grown in culture and tested at a concentration of at least 10' organisms test. Cell density was confirmed by plaing an aliquot of the suspension, growing the organism and counting the number of colonies formed. None of the organisms listed below gave a positive result in the STREP OIA test.
| Staphylococcus aureus | Salmonella cholerarsuis |
|---|---|
| (Protein A Producer) | subspecies cholerarsuis |
| Staphylococcus aureus | serotype: typhimurium |
| Enterococcus faecalis | Gardnerella vaginalis |
| Staphylococcus epidermidis | Streptococcus Group A |
| Moraxella catarrhalis | Streptococcus Group F |
| Klebsiella pneumoniae | Eubacterium lentum |
| Pseudomonas aeruginosa | Streptococcus Group G |
| Escherichia coli | Haemophilus influenzae |
| Streptococcus pneumoniae | Streptococcus equi, ssp. equi |
| Lactobacillus fermentum | Acinetobacter calcoaceticus |
| Peptostreptococcus anaerobius | Candida glabrata |
| Proteus mirabilis | Neisseria gonorrhoeae |
| Salmonella cholerarsuis | Moraxella lacunata |
| subspecies cholerarsuis | Peptostreptococcus productu |
| serotype: minnesota | Candida albicans |
| Salmonella cholerarsuis | |
| subspecies cholerarsuis |
In addition, these organisms were cultured and tested and found to not interfere with the test.
- HSV-I HSV-2 Trichomonas vaginalis
Interfering Substances:
The following substances have been tested and the STREP B OLA test methodology: urine, amniotic fluid, vaginal mucous and sheep blood agar.
H. Summary of clinical testing [§807.92(b)(2)]:
The performance of the STREP B OIA assy was compared to that of routine microbiological Trypticase Soy Agar with 5% Sheep Blood (TSA) culture media and selective broth culture using Lim broth in a prospective evaluation of clinical specimens taken from women in the STREP B OLA test with Selective broth culture, cervical specimens were collected using standard techniques from 947 women using a dual swab (Duo-Transuber swabs-Medical Wire and Equipment Co., Spara, N). One swab was plated onto TSA within 24 hours of collection i im broth oversight. In addition, the pledget from the was placed in Lim broth, incubated and subcultured (10 ul) at 18-24 hours to a TSA plate. All plats were incubated in 5% C0 at 35-37°C. If beta-hemolytic streptococal colonies were selected and confirmed using a streptococal group serotyping method. The other swab was assayed in the STREP B OIA test within 24 hours of collection.
Of the 947 samples tested, 199 vere positive by Lim broth, 121 (60.8%) were also positive by direct agar culture. 127 (63.8%) of the Lim broth positive samples were positive by the OLA method. Of the 748 Lim broth culture regative by TSA and 698 (93.3%) were negative by the STREP B OIA test.
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510(k) SUMMARY (page 5 of 5)
The density of the GBS culture was judged by the TSA blood ager plate. Growin in the first quadman is graded in 11,14000 fco March 1, 1 third quadrant 3-t, and fourth quadesty data were available for 19912 (98.3%) TSA culture positives and 19/199 (59.8%) of cultures positive by Lim broth. The sensitivity of the STREP B OIA assay for the degrees of culture density is as follows:
| Culture Density | % OIA Positive |
|---|---|
| 4+ | 100% (31/31) |
| 3+ | 88 % (30/34) |
| 2+ | 83 % (15/18) |
| 1+ | 67 % (24/36) |
| Broth Only | 34 % (27/79) |
Broth only results were for samples that were negative on direct BAP culture but positive by either swab or pledget broth.
COMPARISON of STREP B OIA to Lim Broth Culture 947 SAMPLES
| OIA | |||
|---|---|---|---|
| + | - | ||
| Lim Broth |
- | 127 | 72 | Sensitivity = 63.8% CI (56.7-70.5%)* |
| Culture
- | 50 | 698 | Specificity = 93.3% CI (91.3-95.0%)* |
COMPARISON of TSA Culture to Lim Broth Culture 947 SAMPLES
| TSA Culture | |||
|---|---|---|---|
| + | - | ||
| Lim Broth | |||
| Culture | 121 | 78 | Sensitivity = 60.8% CI (53.7-67.6%) |
| 3 | 745 | Specificity = 99.6% CI (98.8-99.9%) |
- 95 % Confidence Interval
I. Conclusions from nonclinical / clinical testing {§807.92(b)(3)):
See sections G and H above.
J. Additional information [§807.92(d)]:
No additional information has been requested by FDA at this time.
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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a bird-like figure with three curved lines representing its wings or feathers. The overall design is simple and professional, conveying a sense of authority and trustworthiness.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 19 1999
Roger C. Briden, Ph.D. Director of Regulatory Affairs BioStar, Inc. 6655 Lookout Road Boulder, Colorado 80301
K991828 Re: Trade Name: Strep B OIA® Regulatory Class: I Product Code: GTY Dated: May 28, 1999 Received: May 28, 1999
Dear Dr. Briden:
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 legally marketed predicate 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 of the Act. The general controls provisions 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, 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 regulations.
6
Rage 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 (770)488-7655.
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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Butman
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
7
12.0 INDICATIONS FOR USE STATEMENT
INDICATIONS FOR USE STATEMENT
| 510(k) Number (if known): | K991828 |
|---|---|
| Device Name: | STREP B OIA® |
Indications For Use:
The BioStar® STREP B OLA® assay is an Optical ImmunoAssay (OTA) test for the rapid detection of group B streptococcal antigen directly from cervical and vaginal swabs from intrapartum maternity patients. The STREP B OIA assay is intended for use as an adjunct to culture, clinical observation and other information available to the physician.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
urols vision Sign Off) Division of Clinical Laboratory Devices K 99 1828 510(k) Number.
) Number K 9478
OR
Over-The-Counter Use
Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96)