Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard PCR-based diagnostic test with automated sample processing. There is no mention of AI, ML, or any data analysis techniques that would suggest the use of such technologies. The performance studies focus on traditional analytical and clinical validation metrics.

Therapeutic

No.
This device is an in vitro diagnostic test used to detect Group B Streptococcus (GBS) DNA to aid in determining colonization status. It does not directly treat or provide therapy.

Diagnostic

Yes

The document explicitly states that the device is a "qualitative in vitro diagnostic test" designed to detect Group B Streptococcus (GBS) DNA, and its results can be used as an "aid in determining colonization status in antepartum women." These functions fall under the definition of a diagnostic device.

SaMD (Software as a Medical Device)

No

The device is an in vitro diagnostic test that incorporates automated DNA extraction and real-time PCR, which are hardware-dependent processes. It is not solely software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use/Indications for Use: The very first sentence explicitly states it is a "qualitative in vitro diagnostic test".
Device Description: This section also reiterates that it is a "qualitative in vitro diagnostic test".
Function: The device is designed to detect Group B Streptococcus (GBS) DNA in Lim Broth cultures obtained from patient specimens (vaginal and rectal swabs). This process of analyzing biological samples outside of the body to aid in diagnosis or determining a medical condition is the core definition of an in vitro diagnostic device.
Purpose: The results are used "as an aid in determining colonization status in antepartum women," which is a diagnostic purpose.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The BD MAX™ GBS Assay as implemented on the BD MAX™ System is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA in Lim Broth cultures after incubation for greater than or equal to (>)18 hours, obtained from vaginal and rectal swab specimens from antepartum pregnant women. The test incorporates automated DNA extraction to isolate the target nucleic acid from the specimen and real-time polymerase chain reaction (PCR) to detect a 124 bp region of the cfb gene sequence of the Streptococcus agalactiae chromosome. Results from the BD MAX GBS Assay can be used as an aid in determining colonization status in antepartum women.

The BD MAX™ GBS Assay does not provide susceptibility results. Cultured isolates are necessary for performing susceptibility testing as recommended for penicillin-allergic women. Subculture to solid media for additional testing when indicated.

Product codes (comma separated list FDA assigned to the subject device)

NJR, OOI

Device Description

The BD MAX™ GBS Assay as implemented on the BD MAX™ System is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA in Lim Broth cultures after incubation for greater than or equal to (>)18 hours, obtained from vaginal and rectal swab specimens from antepartum pregnant women. The test incorporates automated DNA extraction to isolate the target nucleic acid from the specimen and real-time polymerase chain reaction (PCR) to detect a 124 bp region of the cfb gene sequence of the Streptococcus agalactiae chromosome. Results from the BD MAX GBS Assay can be used as an aid in determining colonization status in antepartum women.

The BD MAX™ GBS Assay does not provide susceptibility results. Cultured isolates are necessary for performing susceptibility testing as recommended for penicillin-allergic women. Subculture to solid media for additional testing when indicated.

A vaginal and rectal swab is collected and transported to the laboratory using standard bacterial swab transport systems containing a non-nutritive transport medium (e.g. Amies or Stuart). In the lab, the swab is removed from the transport medium and placed into selective Lim Broth [Todd-Hewitt Broth supplemented with colistin (10μg/mL) and nalidixic acid (15µg/mL)]. After incubation of inoculated Lim Broth culture for >18 hours at 37 ℃ in ambient air or 5 % CO2, a 15 µL aliquot of the broth is mixed with BD MAX GBS Sample Preparation Reagent and processed on the BD MAX System using the BD MAX GBS Assay. The BD MAX System automatically extracts the target nucleic acid and amplifies a section of the cfb gene sequence of the GBS chromosome, if present. The BD MAX GBS Assay includes an Internal Process Control to monitor for the presence of potential inhibitory substances as well as system or reagent failures that may be encountered during the entire process.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

vaginal and rectal swab specimens

Indicated Patient Age Range

antepartum pregnant women

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

A 3-site prospective investigational study was conducted. Specimens were collected by health care providers using the CDC recommended procedure: "Swab the lower vagina (vaginal introitus), followed by the rectum (i.e., insert swab through the anal sphincter) using the same swab or two different swabs." Swabs were sent for culture-based analysis to be performed by laboratories at three separate metropolitan locations in the U.S. Following incubation of the vaginal and rectal swab specimens for >18 hours in selective Lim Broth medium, a 15 µL aliquot of this enriched broth was tested using the BD MAX GBS Assay to ascertain the clinical sensitivity and specificity of the BD MAX GBS Assay as compared to the reference culture method based on CDC recommendations.

To perform the culture based analysis, the enriched Lim Broth specimens were then subcultured to a sheep blood agar plate and incubated up to 48 hours. Colonies suggestive of GBS were then Gram stained and tested for catalase production. Gram positive/catalase negative colonies were then specifically identified by the appropriate confirmatory method. Beta hemolytic GBS colonies were confirmed using a latex agglutination test method and gamma hemolytic GBS colonies were confirmed by performing a CAMP reaction.

Of the 631 clinical specimens enrolled in the study, 601 were compliant and included in the statistical analyses.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Precision Study:
Qualitative testing was performed over a 12 day period to determine within laboratory precision using the BD MAX GBS Assay. Precision was determined within instrument as well as across instruments. For consistency, testing was performed using the same lot of BD MAX GBS Assay. Panel members were prepared at five levels, which included four concentrations of GBS along with True Negative (TN) samples. The levels of the panel members were determined by relation to the Limit of Detection (LoD) of the assay. The Moderate Positive (MP) sample was at a concentration of ~3X LoD, the Low Positive (LP) sample was at a level of ~1.5X LoD, the High Negative 2 (HN-2) sample was at a ~10 fold dilution of the LoD and the High Negative 1 (HN-1) sample was at a ~100 fold dilution of the LoD. Four replicates of each panel member were tested over a 12 day period with two runs per day on three different instruments by multiple operators.

Reproducibility Study:
Qualitative testing was performed to determine reproducibility using the BD MAX GBS Assay. Reproducibility was determined within site as well as across sites. Panel members were prepared at four levels, which included three concentrations of GBS along with True Negative (TN) samples. The Moderate Positive (MP) sample was at a concentration of ~2X LoD, the Low Positive (LP) sample was at a level of ~1X LoD, the High Negative (HN) sample was at a concentration of ~100 fold dilution of the LoD. Six replicates of each panel member were tested at 3 sites across 5 runs over a minimum of a 3 day period.

Carry-over/Cross Contamination Study:
A study was conducted to investigate within-run carry-over and between-run carry-over. All High Positive samples that gave a positive result were accurately identified as positive while all of the True Negative samples were accurately identified as negative. IND results were due to PCR failure as neither Target or Process control were amplified. This study demonstrated the absence of carry-over and cross-contamination either within a run or between successive runs using the GBS assay on the BD MAX System.

Effectiveness of Control Study:
The BD MAX GBS Assay was performed with variations to critical assay and/or process conditions on the automated BD MAX System to demonstrate the effectiveness of the internal process controls incorporated as part of the assay. The BD MAX GBS Assay was also performed in the presence of known inhibitory factors to demonstrate the effectiveness of the internal process control to monitor for inhibition. The data demonstrates the effectiveness of the internal process control to monitor for inhibition that may prevent detection of low levels of target and potentially lead to False negative errors.

Interfering Substances Study:
The BD MAX GBS Assay was tested in the presence of both endogenous and exogenous interfering agents to characterize the ability of the assay to detect GBS DNA under these conditions. The study was performed at GBS concentrations of 300 CFU/mL and 3000 CFU/mL of Sample Preparation Reagent. Interference was also studied in the presence of high concentrations of 127 relevant non-target organisms. The BD MAX GBS Assay was able to detect GBS at a concentration of 300 CFU/mL of Sample Preparation Reagent in the presence of all interfering agents tested except body powder and feces where one of the three replicates was called negative. At 3000 CFU/mL of Sample Preparation Reagent no interference was observed with these agents.

Analytical Sensitivity Limit of Detection Study:
The Limit of Detection (LoD) of the BD MAX GBS Assay is 200 CFU/mL Sample Preparation Reagent (2x104 CFU/mL enriched Lim broth). Hit rate (95% positivity) method was used to determine the LoD. Pooled Clinical Negative samples spiked with GBS culture and individual clinical negative specimen spiked with GBS culture were used in the determination of LoD.

Microbial Variants Study:
The ability of the BD MAX GBS Assay to detect multiple GBS serotypes was demonstrated using 12 different strains of GBS bacteria. The BD MAX GBS Assay was able to detect all major serotypes of GBS at 300 CFU/mL Sample Preparation Reagent (3x104 CFU/mL incubated Lim broth culture).

Analytical Specificity Study:
The BD MAX GBS Assay was performed on samples containing high levels of nontarget organisms, using the BD MAX System, to demonstrate the specificity of the assay for detection of Group B Streptococcus. A total of 127 organisms were tested (119 viable organisms and 8 genomic DNA). None of the 11 phylogenetically related streptococcal isolates tested positive with the BD MAX GBS Assay. Of the remaining strains tested only one (Moraxella osloensis) was positive in four of nine replicates.

Clinical Performance Study:
Performance characteristics of the BD MAX GBS Assay were determined in a 3-site prospective investigational study.
Total samples: 601 compliant specimens.
Detected GBS positive: 133, Detected GBS negative: 446.
False positive: 15, False negative: 7.
Overall Sensitivity: 95.0 % (133/140) (95 % CI: 90.0 - 98.0 %)
Overall Specificity: 96.7 % (446/461) (95 % CI: 94.7 - 98.2 %)
Overall Prevalence: 23.0 % (143/623) (95 % CI: 19.7 - 26.5 %)

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

SENSITIVITY: 95.0 % (133/140) CI (90.0 - 98.0 %)
SPECIFICITY: 96.7 % (446/461) CI (94.7 - 98.2 %)
PREVALENCE: 23.0 % (143/623) CI (19.7 - 26.5 %)

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K062948 Cepheid Smart GBS Assay

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

0

MAY 2 7 2010

K090191 510k Summary BD MAX GBS Assay

Per 21 CFR Sec. 807.92

Supplement Date: May 24, 2010

Submitted by: HandyLab, Inc.( a wholly owned subsidiary of Becton, Dickinson and Company) 5230 S. State Road Ann Arbor, MI, 48108, USA

Contact Information: Mrs. Martha J. Rumford Director QA/RA Martha_Rumford@BD.com (734) 663-4719 Ext: 225 FAX (734) 663-7837

The name of the device:

BD MAX™ GBS Assay Trade name:

Common or usual name: Group B Strep Assay

Product Codes:	NJR
Classification name:	NUCLEIC ACID AMPLIFICATION ASSAY SYSTEM,
GROUP B STREPTOCOCCUS, DIRECT SPECIMEN TEST
Regulation number:	866.3740

CLASS I

Classification Panel MICROBIOLOGY

Predicate Device(s): K062948 Cepheid Smart GBS Assay

DEVICE DESCRIPTION

INTENDED USE

-i-i

The BD MAX™ GBS Assay as implemented on the BD MAX™ System is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA in Lim Broth cultures after incubation for greater than or equal to (>)18 hours, obtained from vaginal and rectal swab specimens from antepartum pregnant women. The test incorporates automated DNA extraction to isolate the target nucleic acid from the specimen and real-time polymerase chain reaction (PCR) to detect a 124 bp region of

1

the cfb gene sequence of the Streptococcus agalactiae chromosome. Results from the BD MAX GBS Assay can be used as an aid in determining colonization status in antepartum women.

The BD MAX™ GBS Assay does not provide susceptibility results. Cultured isolates are necessary for performing susceptibility testing as recommended for penicillin-allergic women. Subculture to solid media for additional testing when indicated.

SUMMARY AND EXPLANATION OF THE PROCEDURE

A vaginal and rectal swab is collected and transported to the laboratory using standard bacterial swab transport systems containing a non-nutritive transport medium (e.g. Amies or Stuart). In the lab, the swab is removed from the transport medium and placed into selective Lim Broth [Todd-Hewitt Broth supplemented with colistin (10μg/mL) and nalidixic acid (15µg/mL)]. After incubation of inoculated Lim Broth culture for >18 hours at 37 ℃ in ambient air or 5 % CO2, a 15 µL aliquot of the broth is mixed with BD MAX GBS Sample Preparation Reagent and processed on the BD MAX System using the BD MAX GBS Assay. The BD MAX System automatically extracts the target nucleic acid and amplifies a section of the cfb gene sequence of the GBS chromosome, if present. The BD MAX GBS Assay includes an Internal Process Control to monitor for the presence of potential inhibitory substances as well as system or reagent failures that may be encountered during the entire process.

Group B Streptococcus (GBS) is a Gram positive bacterium found in the lower intestinal tract of 10-30 % of all healthy adults. A person who carries GBS but does not show signs of GBS disease is said to be "colonized" with GBS. GBS colonization is not contagious and GBS are commonly found bacteria associated with the human body. Under certain circumstances, GBS can invade the mody and cause serious infection; this is referred to as Group B streptococcal disease. GBS can cause severe disease in a newborn and is known to be the leading cause of life threatening bacterial infections in newborns. A number of strains of the pathogen circulate in the community, and approximately 80 % of newborn infections are acquired during birth by vertical (mother-to-baby) transmission. Research has shown that GBS colonizes the anogenital mucosa of 25-40 % of healthy women, and despite the introduction of antibiotic prophylaxis in the US, GBS still causes approximately 2,500 cases of newborn infections per year. Of those infected, 25 % incur serious long-term consequences such as deafness, blindness and neurological damage. Approximately 100 babies die annually in the U.S. in the first three months of life as a result of GBS infection and half of these deaths occur during the first week of life.1

The current standard of care for preventing neonatal GBS disease is screening pregnant women at 35-37 weeks of gestation to determine their GBS colonization status. 1 Most GBS testing is performed by culture and can take up to 48 hours for definitive identification of GBS following the initial >18 hour incubation of vaginal and rectal swabs in a selective broth medium. The BD MAX GBS Assay, as implemented on the BD MAX System, can provide results from up to 24 specimens in approximately 120 minutes after the initial >18 hour incubation/enrichment step. The BD MAX GBS Assay streamlines and simplifies the testing process by eliminating the need for operator intervention from the time the sample is placed onto the BD MAX System until results are available.

Image /page/1/Picture/6 description: The image shows a close-up of a heavily pixelated and distorted image. The image appears to contain some text, but the pixelation makes it difficult to read. The text seems to be arranged vertically, and the overall impression is one of low image quality and significant data loss.

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Substantial Equivalence Table

・

Item Being	BD MAX	Smart	Same	Different
Compared	GBS Assay	GBS Assay
Intended Use	The BD MAX™ GBS Assay as
implemented on the BD MAX TM
System is a qualitative
in vitro diagnostic test designed
to detect Group B
Streptococcus (GBS) DNA in
Lim Broth cultures after
incubation for greater than or
equal to (>)18 hours, obtained
from vaginal and rectal swab
specimens from antepartum
pregnant women. The test
incorporates automated DNA
extraction to isolate the target
nucleic acid from the specimen
and real-time polymerase chain
reaction (PCR) to detect a 124
bp region of the cfb gene
sequence of the Streptococcus
agalactiae chromosome.
Results from the BD MAX GBS
Assay can be used as an aid in
determining colonization status
in antepartum women.
The BD MAX™ GBS Assay
does not provide susceptibility
results. Cultured isolates are
needed for performing
susceptibility testing as
recommended for penicillin-
allergic women. Subculture to
solid media for additional
testing when indicated.	Same - Assay testing is
indicated for
identification of GBS
colonization in
antepartum women
Smart GBS Assay
testing is also indicated
for in intrapartum
women
The Smart GBS Assay
does not provide
susceptibility results.
Culture isolates are
needed for performing
susceptibility testing as
recommended for
penicillin-allergic	x	X
Analyte	Group B Streptococci
DNA	women.
Same	X
Specimen Type	Vaginal and Rectal	Same	X
Specimen
collection media
type	Amies or Stuart	Copan or Stuart	X
Sample
Preparation
Method	Sample Preparation for
Nucleic Acid extraction is
automated on BD MAX
System	Incorporates a manual
sample preparation
process		x
Sample
Processing	Enriched in overnight LIM	Direct swab method or
Enriched in overnight
LIM	X	X
	Platform	BD MAX System
(random access)	Cepheid SmartCylcer Dx
(batch)		x
	Assay Format	Real Time Fluorogenic detection of PCR amplification	Same	x
	Probes	Scorpion	Taqman		x
	Single Use	Yes	yes	x
	User / skill required	Moderately complex

no special skills required
built in protocol
no data interpretation required. | Highly complex
(Smart Cycle)
Moderately complex
(Gene Expert) | x | x |
| | Automatic Assay | Yes - built-in result interpretation | Yes | x | |
| | Internal Process Control | Extraction and PCR internal process control is a process monitor | Probe Check | | x |
| | External Control | Materials available commercially but not required to run the test | Materials available commercially but not required to run the test | x | |

ﺗ

:

BD MAX GBS Assay 510(k) summary

:

ﻤﺎﺗ

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ist
Press

PERFORMANCE DATA

Precision

Qualitative testing was performed over a 12 day period in order to determine within laboratory precision using the BD MAX GBS Assay. Precision was determined within instrument as well as across instruments. For consistency, testing was performed using the same lot of BD MAX GBS Assay. Panel members were prepared at five levels, which included four concentrations of GBS along with True Negative (TN) samples. The levels of the panel members were determined by relation to the Limit of Detection (LoD) of the assay. The Moderate Positive (MP) sample was at a concentration of ~3X LoD, the Low Positive (LP) sample was at a level of ~1.5X LoD, the High Negative 2 (HN-2) sample was at a ~10 fold dilution of the LoD and the High Negative 1 (HN-1) sample was at a ~100 fold dilution of the LoD. Four replicates of each panel member were tested over a 12 day period with two runs per day on three different instruments by multiple operators.

Reproducibility

Qualitative testing was performed in order to determine reproducibility using the BD MAX GBS Assay. Reproducibility was determined within site as well as across sites. Panel members were prepared at four leve); , which included three concentrations of GBS along with True Negative (TN) sampless. The levels of the panel members were determined by relation to the Limit of Detection (LoD) of the assay. The Moderate Positive (MP) sample was at a concentration of ~2X LoD, the Low Positive (LP) sample was at a level of ~1X LoD, the High Negative (HN) sample was at a concentration of

4

~100 fold dilution of the LoD. Six replicates of each panel member were tested at 3 sites. across 5 runs over a minimum of a 3 day period.

Carry over/Cross Contamination

A study was conducted to investigate within-run carry-over and between-run carry-over. All High Positive samples that gave a and result were accurately identified as positive while all of the True Negative sampless were accurately identified as negative. IND results were due to PCR failure as netther Target or Process control were amplified. This study demonstrated the absence of carry-over and cross-contamination either within a run or between successive runs using the GBS assay on the BD MAX System.

Effectiveness of Control

The BD MAX GBS Assay was performed with variations to critical assay and/or process conditions on the automated BD MAX System to demonstrate the effectiveness of the internal process controls incorporated as part of the assay. The BD MAX GBS Assay was also performed in the presence of known inhibitory factors to demonstrate the effectiveness of the internal process control to monitor for inhibition. Of the 4 critical assay conditions that were tested on the automated Jaquar system, the BD MAX GBS Assay will fail if any one of the following 3 critical assay conditions fail - (i) absence of Reagent 1, (ii) absence of Reagent 2, and (iii) absence of Reagent 3 from the strip. As a result the incorporation of the internal process control controls for the occurrence of errors due to the use of 'bad' reagents or errors due to some fluidic system malfunction resulting in the non-aspiration of these reagents from the reservoirs. In addition, the presence of an inhibitory agent (spermicidal jelly) leads to inhibition of the internal process control resulting in a higher Ct value than a sample without the agent. The data demonstrates the effectiveness of the internal process control to monitor for inhibition that may prevent detection of low levels of target and potentially lead to False negative errors. For the samples that had the specimen omitted, the internal process control was still detected at normal levels becausa the internal process control pellet present in the test strip (and exogenous to the spectinen) amplified to give a valid result.

Interfering Substances

The BD MAX GBS Assay was tested in the presence of both endogenous and exogenous interfering agents to characterize the ability of the assay to detect GBS DNA under these conditions. The study was performed at GBS concentrations of 300 CFU/mL and 3000 CFU/mL of Sample Preparation Reagent. Interference was also studied in the presence of high concentrations of 127 relevant non-target organisms to determine if the detection of GBS at 300 CFU/mL was affected by the presence of these organisms. The list of organisms and concentration tested are the same as listed in Analytical Specificity section. The following exogenous interfering substances were tested: miconazole (fungicide), hemorrhoid cooling gel, spermicidal foam (nonoxynol 9),spermicidal gel (nonoxynol 9), contraceptive gel, deodorant spray, lubricating gel, moisturizing lotion, body oil and body powder. A complete swab of exogenous agent, similar to the collection of a GBS swab, was added to neqative LIM broth and released into the specimen. The specimen (15ul) with the interfering agent was added to the Sample Preparation Reagent tube. The following endogenous substances were tested: human DNA (1.55 x 103 ng /mL Sample Preparation Reagent), whole blood (10% in Lim), urine

Image /page/4/Picture/8 description: The image shows a blurry, black and white graphic. The graphic appears to be a logo or emblem, but the details are not clear due to the low resolution and blurriness. The shapes are abstract and difficult to discern, but there are some vertical lines and curved shapes.

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(30% in Lim), mucous (one Swab in Lim), amniotic fluid (10% in Lim), and feces (one swab in Lim).

Interference (1/3 replicates) was observed in the presence of Corynebacterium xerosis, Serratia marcescans and EBV when tested at a GBS target concentration of 300 CFU/mL of Sample Preparation Reagent.

The BD MAX GBS Assay was able to detect GBS at a concentration of 300 CFU/mL of Sample Preparation Reagent in the presence of all interfering agents tested except body powder and feces where one of the three replicates was called negative. At 3000 CFU/mL of Sample Preparation Reagent no interference was observed with these agents.

Analytical Sensitivity Limit of Detection Study

The Limit of Detection (LoD) of the Book MAX GBS Assay is 200 CFU/mL Sample Preparation Reagent (2x104 CFU/mL enriched Lim broth). Hit rate (95% positivity) method was used to determine the LoD. Pooled Clinical Neqative samples spiked with GBS culture was used and individual clinical negative specimen spiked with GBS culture were used in the determination of LoD.

Microbial Variants

The ability of the BD MAX GBS Assay to detect multiple GBS serotypes was demonstrated using 12 different strains of GBS bacteria listed in Table 4. The BD MAX GBS Assay was able to detect all major serotypes of GBS at 300 CFU/mL Sample Preparation Reagent (3x104 CFU/mL incubated Lim broth culture).

Analytical Specificity

The BD MAX GBS Assay was performed on samples containing high levels of nontarget organisms, using the BD MAX System, to demonstrate the specificity of the assay for detection of Group B Streptococcus. A total of 127 organisms were tested (119 viable organisms and 8 genomic DNA), including 11 organisms phylogenetically similar to Group B Streptococcus and a wide variety of other organisms including viruses, fungi and parasites that are known to infect the urogenital tract or are part of urogenital microflora.. The Internal Process Control was detected in all specimens. None of the 11 phylogenetically related streptococcal isolates tested positive with the BD MAX GBS Assay. Of the remaining strains tested only one (Moraxella osloensis) was positive in four of nine replicates.

Clinical Performance

Performance characteristics of the BD MAX GBS Assay were determined in a 3-site prospective investigational study. Specimens were collected by health care providers using the procedure recommended by Centers for Disease Control and Prevention that is described as follows: "Swab the lower vagina (vaginal introitus), followed by the rectum (i.e., insert swab through the anal sphincter) using the same swab or two different swabs." Swabs were sent for culture-based analysis to be performed by laboratories at three separate metropolitan locations in the U.S. Following incubation of the vaginal and rectal swab specimens for >18 hours in selective Lim Broth medium, a 15 µL aliquot of this enriched broth was tested using the BD MAX GBS Assay to

6

ascertain the clinical sensitivity and Wecificity of the BD MAX GBS Assay as compared to the reference culture method based on CDC recommendations.1

To perform the culture based analysis, the enriched Lim Broth specimens were then subcultured to a sheep blood agar plate and incubated up to 48 hours. Colonies suggestive of GBS were then Gram stained and tested for catalase production. Gram positive/catalase negative colonies were then specifically identified by the appropriate confirmatory method. Beta hemolytic GBS colonies were confirmed using a latex agglutination test method and gamma hemolytic GBS colonies were confirmed by performing a CAMP reaction. Of the 631 clinical specimens enrolled in the study, 601 were compliant and included in the statistical analyses (Table 2).

Table 2: Clinical performance statistics using the BD MAX GBS Assay

	REFERENCE (CULTURE)
All Sites	Positive	Negative	Total
BD MAX
GBS Assay	Positive	133	15	148
	Negative	7	446	453
	Total	140	461	601

Table 3: Summary of Clinical perform statistics using the BD MAX GBS Assay

	SENSITIVITY	SPECIFICITY	PREVALENCE 1
Site 1	97.4 % (37/38)	96.6 % (141/146)	20.0 % (39/195)
Site 2	92.0 % (46/50)	95.3 % (142/148)	25.1 % (50/199)
Site 3	96.2 % (50/52)	97.6 % (163/167)	23.6 % (54/229)
Total
(95 % CI)	95.0 % (133/140)	96.7 % (446/461)	23.0 % (143/623)
	CI (90.0 - 98.0 %)	CI (94.7 - 98.2 %)	CI (19.7 - 26.5 %)

I Prevalence is based on all specimens with compliant culture reference method results.

The conclusions drawn from the nonclinical and clinical tests demonstrate that the device is safe, effective, and performs as well as or better than the legally marketed predicate device identified in paragraph (a)(3) of this section.

Image /page/6/Picture/8 description: The image shows a black and white drawing of a mushroom cloud. The cloud is tall and narrow, with a rounded top and a narrower base. There are two horizontal lines on either side of the cloud. The image is simple and stylized.

7

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Ms. Martha J. Rumford Director QA/RA BD Diagnostics 5230 S. State Rd. Ann Arbor, MI 48108

Y 2 7 201

Re: K090191

Trade/Device Name: BD MAX™ GBS Assay Regulation Number: 21 CFR § 866.3740 Regulation Name: Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test Regulatory Class: Class II Product Codes: NJR, OOI Dated: May 24, 2010 Received: May 26, 2010 .

Dear Ms. Rumford:

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 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) 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 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Rumford

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will-allow-you-to-begin-marketing-your-device.as-described.in-your.Section.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 Parts 801 and 809), please contact the Office of In Viro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Freddie M. Rodrigues.

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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Indications for Use Form

510(k) Number (if known): K090191

Device Name: BD MAX™ GBS ASSAY

_ Indications for .Use :.... _________________________________________________________________________________________________________________________________________________

The BD MAX™ GBS Assay as implemented on the BD MAX™ System is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA in Lim Broth cultures after incubation for greater than or equal to (>)18 hours, obtained from vaginal and rectal swar" specimens from antepartum pregnant women. The test incorporated automated DNA extraction to isolate the target nucleic acid from the specimen and real-time polymerase chain reaction (PCR) to detect a 124 bp region of the cfb gene sequence of the Streptococcus agalactiae chromosome. Results from the BD MAX™ GBS Assay can be used as an aid in determining colonization status in antepartum women.

The BD MAX™ GBS Assay does not provide susceptibility results. Cultured isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women. Subculture to solid media for additional testing when indicated.

Prescription Use	X
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use
(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Offision Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K09019/

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