(116 days)
No
The device description details a rapid immunochromatographic assay based on antibody-antigen reactions and visual interpretation of lines. There is no mention of computational analysis, algorithms, or learning processes.
No
This device is an in vitro diagnostic test for the detection of an antigen, used to aid in diagnosis, not to treat a condition.
Yes
The "Intended Use / Indications for Use" section states that the device is "intended... to aid in the presumptive diagnosis of both pneumococcal pneumonia and pneumococcal meningitis."
No
The device description clearly outlines a physical immunochromatographic assay with a test strip, membrane, and a hinged device, indicating it is a hardware-based diagnostic test, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device 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." The term "in vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Device Description: The description details how the test works by analyzing biological samples (urine and CSF) outside of the patient's body to detect a specific analyte (S. pneumoniae antigen). This process of analyzing samples taken from the body is the core function of an IVD.
- Anatomical Site: The device uses samples from "Urine, Cerebral Spinal Fluid (CSF)," which are biological specimens collected from the patient.
- Performance Studies: The document describes performance studies using "freshly-collected CSF specimens," further confirming the use of biological samples.
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening.
N/A
Intended Use / Indications for Use
The Binax NOW Streptococcus pneumoniae Test is an in vitro rapid immunochromatographic assay (ICT) 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.
Product codes
GTY
Device Description
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. US 91/214051). To perform the test (2 U.S. patents pending), a swab is dipped into the specimen, removed, and then inserted into 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 antibody 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urine, cerebral spinal fluid (CSF)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Binax NOW Streptococcus pneumoniae Test is substantially equivalent to the predicate device, the Wellcogen Bacterial Antigen Test (K854852), for the detection of S. pneumoniae antigen in urine and CSF. The Binax NOW Streptococcus pneumoniae Test has already been cleared for diagnosis of pneumonia using a urine specimen (510(k) number K991762). No new data for the urine application is presented here. This application focusses on performance of the Binax Now Streptococcus pneumoniae Test in diagnosis of meningitis. The claim for CSF performance was based on using freshly collected CSF specimens. Refer PERFORMANCE CHARACTERISTICS.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
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)