(116 days)
The Binax NOW Streptococcus pneumoniae Test is an in vitro rapid immunochromatographic assay for the detection of Streptococcus pneumoniae (S. pneumoniae) antigen in the urine of patients with pneumonia and in the cerebral spinal fluid (CSF) of patients with meningitis. It is intended, in conjunction with culture and other methods, to aid in the presumptive diagnosis of both pneumococcal pneumonia and pneumococcal meningitis.
The Binax NOW Streptococcus pneumoniae Test is an immunochromatographic membrane assay used to detect pneumococcal soluble antigen in human urine and CSF. Rabbit anti-S. pneumoniae antibody, the Sample Line, is adsorbed onto nitrocellulose membrane. Control antibody is adsorbed onto the same membrane as a second stripe. Both rabbit anti-S. pneumoniae and anti-species antibodies are conjugated to visualizing particles that are dried onto an inert fibrous support. The resulting conjugate pad and striped membrane are combined to construct the test strip. This test strip and a well to hold the swab specimen are mounted on opposite sides of a hinged, book-shaped test device (U.S. patent No. 2 U.S. 91/214051). To perform the test (2 U.S. patents pending), a swab is dipped into the specimen, removed, and then inserted into the test device. Reagent A, a buffer solution, is added from a dropper bottle. The device is then closed, bringing the sample into contact with the test strip. Pneumococcal antigen present in the sample reacts to bind anti-S. pneumoniae conjugate antibody. The resulting antigen-conjugate complexes are captured by immobilized anti-S. pneumoniae antibody, forming the Sample Line. Immobilized control antibody captures anti-species conjugate, forming the Control Line. There are no transferring steps, the sample is contained, and results are available within 15 minutes.
Here's an analysis of the provided text regarding the Binax NOW Streptococcus pneumoniae Test, focusing on the acceptance criteria and the study details:
Acceptance Criteria and Study Details for Binax NOW Streptococcus pneumoniae Test
1. Table of Acceptance Criteria and Reported Device Performance
The provided text focuses on the performance of the device in comparison to a predicate device, rather than explicit numerical acceptance criteria for sensitivity, specificity, or predictive values. The primary acceptance criterion implied is "substantial equivalence" to the predicate device, the Wellcogen Bacterial Antigen Kit (K854852).
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (Wellcogen Bacterial Antigen Kit) for detection of S. pneumoniae antigen in CSF of patients with meningitis. | The Binax NOW Streptococcus pneumoniae Test is stated to be "substantially equivalent to the predicate device, the Wellcogen Bacterial Antigen Test (K854852), for the detection of S. pneumoniae antigen in urine and CSF."Regarding CSF, the application "focusses on performance of the Binax Now Streptococcus pneumoniae Test in diagnosis of meningitis." The performance study was done using freshly-collected CSF specimens. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set related to the CSF meningitis application. It only mentions that the study used "freshly-collected CSF specimens."
The document does not specify the country of origin. The study appears to be prospective given the mention of "freshly-collected CSF specimens."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications for establishing the ground truth of the test set.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used for the test set.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
The document does not mention an MRMC comparative effectiveness study involving human readers. The comparison is between two in-vitro diagnostic devices (Binax NOW and the Wellcogen predicate device).
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the study described is a standalone performance study of the Binax NOW Streptococcus pneumoniae Test. This is an in vitro diagnostic assay that provides a visual result, which is then interpreted by a human, but the performance evaluation is of the test's ability to detect the antigen itself.
7. The Type of Ground Truth Used
The ground truth used for the study is culture and other methods. The intended use states that the test acts "in conjunction with culture and other methods, to aid in the presumptive diagnosis of both pneumococcal pneumonia and pneumococcal meningitis." This implies that bacterial culture results from CSF samples would be the primary ground truth, supplemented by other clinical and laboratory findings.
8. The Sample Size for the Training Set
The document does not provide any information regarding a training set or its sample size. This type of in vitro diagnostic device, especially at this stage of development (immunochromatographic assay), typically does not involve machine learning models with distinct "training sets" in the modern sense. The development and optimization of such assays rely on biochemical and immunological principles, followed by performance validation against clinical samples.
9. How the Ground Truth for the Training Set Was Established
As no training set is described in the context of machine learning, this question is not applicable based on the provided document. The ground truth for the performance evaluation (test set) is established through "culture and other methods."
{0}------------------------------------------------
Binax, Inc. Binax NOW Streptococcus pneumoniae Test 510(k) Notification
NOV 3 0 2001
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: KOla5a)
Binax, Inc. Submitter: 217 Read Street Portland, Maine 04103 (207) 772-3988 (Office) (207) 871-5751 (FAX)
- Pamela S. Angell Contact Person: pangell@binax.com (email)
Binax NOW® Streptococcus pneumoniae Test Trade Name:
Strep pneumo ICT, Binax NOW® Strep pneumo Common Name: test
Streptococcus spp. serological reagents (per Classification Name: 21 CFR 8660.3740)
- Wellcogen Bacterial Antigen Kit, 510(k) Predicate Device: number K854852
- The Binax NOW Streptococcus pneumoniae Test Device Description: is an immunochromatographic membrane assay used to detect pneumococcal soluble antigen in human urine and CSF. Rabbit anti-S. pneumoniae antibody, the Sample Line, is membrane. nictrocellulose adsorbed onto Control antibody is adsorbed onto the same membrane as a second stripe. Both rabbit pneumoniae anti-S. and and anti-species antibodies are conjugated to visualizing are dried onto an inert particles that The resulting conjugate fibrous support. pad and striped membrane are combined to construct the test strip. This test strip and a well to hold the swab specimen are mounted on opposite sides of a hinged, booktest device (U.S. patent No . shaped To perform the test (2 U.S. 91/214051). patents pending), a swab is dipped into the specimen, removed, and then inserted into test device. Reagent A, a buffer the solution, is added from a dropper bottle. device is then closed, bringing the The sample into contact with the test strip.
{1}------------------------------------------------
510 (k) SUMARY (Continued)
Pneumococcal antigen present in the sample reacts to bind anti-S. pneumoniae conjugate The resulting antigen-conjugate antibody. complexes are captured by immobilized anti-S. pneumoniae antibody, forming the Sample Immobilized control antibody captures Line. anti-species conjugate, forming the Control Line. There are no transferring steps, the is contained, and results are sample available within 15 minutes.
The Binax NOW Streptococcus pneumoniae Test is an in vitro rapid immunochromatographic detection of assay for the (ICT) Streptococcus pneumoniae (S. pneumoniae) antigen in the urine of patients with pneumonia and in the cerebral spinal fluid (CSF) of patients with meningitis. It is intended, in conjunction with culture and other methods, to aid in the presumptive diagnosis of both pneumococcal pneumonia and pneumococcal meningitis.
Both the Binax NOW® Streptococcus pneumoniae and the Wellcogen Bacterial Antigen Tests Characteristics: are simple rapid tests with a visual result interpretation. Both use a solid phase coated with polyclonal antibody to detect S. pneumoniae in human urine and CSF samples. However, the predicate device is a latex agglutination test employing antibody coated polystyrene beads that agglutinate in the presence of sufficient homologous antigen. The Binax NOW Streptococcus pneumoniae Test is an immunochromatographic assay utilizing a colloidal gold conjugate and an antibody striped membrane to capture and visualize antigen.
The Binax NOW Streptococcus pneumoniae Test Performance Summary: is substantially equivalent to the predicate device, the Wellcogen Bacterial Antigen Test of ટ . detection (K854852), for the pneumoniae antigen in urine and CSF. The Binax NOW Streptococcus pneumoniae Test has diqanosis already been cleared for of pneumonia using a urine specimen (510(k) number K991762). No new data for the urine application is presented here. This
Intended Use:
Technological
{2}------------------------------------------------
510(k) SUMARY (Continued)
application focusses on performance of the Binax Now Streptococcus pneumoniae Test in Dinax Now Berspissis of meningitis. The cor for cho oraginance of the CSF was performance - oing freshly - collected CSF CSF to specimens. Refer PERFORMANCE CHARACTERISTICS.
Signed J. Georges Nitis Ph.D Date 7/3/01
J. Georges Nitis Ph.D., MBA
Director, Regulatory and Clinical Affairs
{3}------------------------------------------------
DEPARTMENT
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Pamela Angell Manager of Regulatory and Clinical Affairs Program Planning and Implementation Binax, Inc. 217 Read Street Portland, ME 04103
NOV 3 0 2001
K012521 Re:
Trade/Device Name: Binax Now® Streptococcus pneumoniae Test Regulation Number: 21 CFR 862.3740 Regulation Name: Streptococcus spp. Serological reagents Regulatory Class: Class I Product Code: GTY Dated: October 31, 2001 Received: November 8, 2001
Dear Ms. Angell:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for are based of to May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered pror to rite) 2017-11-11 accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, iferere, maxis 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r toase of actived that I be mination that your device complies with other requirements of the Act that I Dr Has Intatutes and regulations administered by other Federal agencies. You must or any I oderal the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Fart 607), accessing (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{4}------------------------------------------------
Page 2 -
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 nothication. The I Dri inding of baction 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 CFF Part 801 and 1 If you desire specific acrice for your astic devices), please contact the Office of Compliance at additionally 607.10 for in This diagnestions on the promotion and advertising of your device, (201) 594-4568. Traditionally, 201 - 4639. Also, please note the regulation prease condor the office or Compe to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mionifacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers International and '5020'ss' "http://www.fda.gov/cdrh/dsma/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
{5}------------------------------------------------
Binax, Inc. Binax NOW Streptococcus pneumoniae Test 510(k) Notification
INDICATIONS FOR USE ENCLOSURE
| 510 (k) Number (if known) : | |
|---|---|
| ----------------------------- | -- |
KO12.5a1
Device Name:
Binax NOW Streptococcus pneumoniae Test
Indications For Use:
The Binax NOW Streptococcus pneumoniae Test is an in vitro Ine Billax Now Strepeocouds pholmassay for the detection of rapia induscographiae (S. pneumoniae) antigen in the urine of Streptococcus pheamoniae (or phoameral spinal fluid (CSF) patients with pheamonia and ... It is intended, in conjunction of patients with methingreib.
with culture and other methods, to aid in the presumptive with Curture and Occasi pneumococcal pneumonia and pneumococcal meninqitis.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K01 2521
Prescription Use
(Per 21 CFR 801.109)
OR Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.