(215 days)
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No
The device is a chromogenic culture medium that relies on enzymatic reactions and color changes for detection, not AI/ML. The summary explicitly states "Not Found" for mentions of AI, DNN, or ML, and describes a purely biological and chemical detection method.
No
The device is intended for the qualitative detection of nasal colonization by MRSA to aid in prevention and control of MRSA infections, and explicitly states it is "not intended to diagnose MRSA infection nor to guide or monitor therapy for MRSA infections."
No
The 'Intended Use' section explicitly states, "HardyCHROM™ MRSA is not intended to diagnose MRSA infection nor to guide or monitor therapy for MRSA infections." Its purpose is for qualitative detection of nasal colonization to aid in prevention and control.
No
The device is a chromogenic culture medium, which is a physical substance used in laboratory testing, not a software program.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is for the "qualitative detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA infections in health care settings." This involves testing a sample (anterior nares swabs) taken from the human body to provide information about a health condition (MRSA colonization).
- Device Description: It describes a medium used to grow and identify microorganisms from a clinical specimen based on their enzymatic activity and resulting color change. This is a classic method used in in vitro diagnostics.
- Clinical Studies: The document details clinical studies where the device was used to test human samples (anterior nasal swab samples) and the results were compared to other laboratory methods. This is a requirement for demonstrating the performance of an IVD.
- Performance Metrics: The document provides performance metrics like Sensitivity and Specificity, which are standard measures used to evaluate the accuracy of diagnostic tests.
All these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
HardyCHROM™ MRSA is a selective and differential chromogenic medium recommended for the qualitative detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA infections in health care settings. The test is performed on anterior nares swabs from patients and healthcare workers to screen for MRSA colonization. HardyCHROM™ MRSA is not intended to diagnose MRSA infection nor to guide or monitor therapy for MRSA infections. Concomitant cultures are necessary to recover organisms for susceptibility testing or epidemiological typing. A negative result does not preclude MRSA nasal colonization.
Product codes (comma separated list FDA assigned to the subject device)
JSO
Device Description
HardyCHROM™ MRSA is translucent and light amber in color and contains chromogens that release chromophores when cleaved by enzymes produced by methicillin resistant Staphylococcus aureus (MRSA) strains. Based on colony color, HardyCHROM™M MRSA allows for the reliable detection of most MRSA from clinical specimens in less than 24 hours based on the appearance of a pink/magenta colored colony. Non-MRSA strains are either inhibited by the addition of selective agents or utilize different chromogenic substrates in the media to produce different colored colonies. If none of the substrates are utilized, natural or white colored colonies will be present. If plates are negative for growth after 24 hours, it is recommended to re-incubatc for an additional 24 hours.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
anterior nares
Indicated Patient Age Range
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Intended User / Care Setting
health care settings
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Description of the test set: The clinical study involved the evaluation of HardyCHROM™ MRSA plates at three geographically diverse hospitals and clinics using surveillance specimens of anterior nasal swab samples.
Sample size: A total of four hundred forty-three (443) samples were evaluated.
Data source: Surveillance specimens of anterior nasal swab samples from patients.
Annotation protocol: For the purpose of this study, one nasal specimen swab was used to inoculate a Blood Agar plate first, followed by a HardyCHROM™ MRSA plate. A second swab from the same patient was used to inoculate a plate of commercial chromogenic MRSA medium. All plates were incubated following standard lab procedures for Blood Agar and manufacturer's instructions for the commercial chromogenic MRSA medium and HardyCHROM™ MRSA plates, aerobically at 35°-37°C (non-CO2), and read at 24 and 48 hours. Colonies suspected to be S. aureus on Blood Agar were confirmed with a StaphTEX latex agglutination test, and further characterization for MRSA was done using a PBP2' test, oxacillin disk (1ug), and cefoxitin disk (30μg) diffusion, according to CLSI guidelines M100-S20.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Clinical study at three geographically diverse hospitals and clinics.
Sample Size: 443 anterior nasal swab samples.
Standalone Performance:
- HardyCHROM™ MRSA vs. Traditional Culture (24 hours):
- Positive Percent Agreement: 93.3% (126/135) (95% CI 89.6-98.4%)
- Negative Percent Agreement: 99.7% (307/308) (95% CI 98.9 - 100%)
- HardyCHROM™ MRSA vs. Traditional Culture (48 hours):
- Positive Percent Agreement: 97.0% (131/135) (95% CI 89.6-98.5%)
- Negative Percent Agreement: 99.7% (307/308) (95% CI 98.9 - 100%)
- HardyCHROM™ MRSA vs. Commercial Chromogenic MRSA Medium (24 hours):
- Positive Percent Agreement: 98.3% (118/120) (95% CI 97.5 – 99.3%)
- Negative Percent Agreement: 97.5% (315/323) (95% CI 98.9 – 100%)
- HardyCHROM™ MRSA vs. Commercial Chromogenic MRSA Medium (48 hours):
- Positive Percent Agreement: 98.4% (122/124) (95% CI 97.5 - 99.3%)
- Negative Percent Agreement: 96.9% (309/319) (95% CI 89.6 - 98.4%)
- HardyCHROM™ MRSA vs. PBP2' (24 hours):
- Positive Percent Agreement: 93.3% (95% CI 89.6 – 98.4%)
- Negative Percent Agreement: 99.7% (95% CI 98.9 – 100%)
- HardyCHROM™ MRSA vs. PBP2' (48 hours):
- Positive Percent Agreement: 97.0% (95% CI 89.6-98.5%)
- Negative Percent Agreement: 99.7% (95% CI 98.9 - 100%)
- HardyCHROM™ MRSA vs. Cefoxitin Disk 30ug (24 hours):
- Positive Percent Agreement: 93.3% (95% CI 89.6 – 98.4%)
- Negative Percent Agreement: 99.7% (95% CI 98.9 – 100%)
- HardyCHROM™ MRSA vs. Cefoxitin 30ug Disk (48 hours):
- Positive Percent Agreement: 97.0% (95% CI 89.6-98.5%)
- Negative Percent Agreement: 99.7% (95% CI 98.9 - 100%)
- HardyCHROM™ MRSA vs. Oxacillin Disk 1ug (24 hours):
- Positive Percent Agreement: 93.3% (95% CI 89.6 – 98.4%)
- Negative Percent Agreement: 99.7% (95% CI 98.9 – 100%)
- HardyCHROM™ MRSA vs. Oxacillin Disk 1ug (48 hours):
- Positive Percent Agreement: 97.0% (95% CI 89.6-98.5%)
- Negative Percent Agreement: 99.7% (95% CI 98.9 - 100%)
Key Results:
- HardyCHROM™ MRSA demonstrated high agreement with traditional culture methods for both MRSA and non-MRSA detection, with improved sensitivity at 48 hours.
- It showed strong agreement with a commercial chromogenic MRSA medium.
- Performance was also consistent with PBP2', cefoxitin, and oxacillin disk diffusion methods for identifying MRSA.
- Reproducibility studies performed in a clinical laboratory setting showed 100% reproducibility for both inter-lot and overall testing intervals, with 100% sensitivity for MRSA and 100% specificity for MSSA.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
HardyCHROM™ MRSA vs. Traditional Culture (24 hours):
- Sensitivity: Not explicitly stated as "sensitivity", but Positive Percent Agreement is 93.3% (126/135)
- Specificity: Not explicitly stated as "specificity", but Negative Percent Agreement is 99.7% (307/308)
HardyCHROM™ MRSA vs. Traditional Culture (48 hours):
- Sensitivity: Not explicitly stated as "sensitivity", but Positive Percent Agreement is 97.0% (131/135)
- Specificity: Not explicitly stated as "specificity", but Negative Percent Agreement is 99.7% (307/308)
HardyCHROM™ MRSA vs. Commercial Chromogenic MRSA Medium (24 hours):
- Sensitivity: Not explicitly stated as "sensitivity", but Positive Percent Agreement is 98.3% (118/120)
- Specificity: Not explicitly stated as "specificity", but Negative Percent Agreement is 97.5% (315/323)
HardyCHROM™ MRSA vs. Commercial Chromogenic MRSA Medium (48 hours):
- Sensitivity: Not explicitly stated as "sensitivity", but Positive Percent Agreement is 98.4% (122/124)
- Specificity: Not explicitly stated as "specificity", but Negative Percent Agreement is 96.9% (309/319)
Agreement with PBP2', cefoxitin (30μg) and oxacillin (1μg) disk testing:
- Sensitivity: 93.3% at 24 hours and 97.0% at 48 hours for mecA mediated MRSA.
- Specificity: 99.7% for non-MRSA at both 24 and 48 hours.
Clinical Laboratory Setting Reproducibility Testing:
- Sensitivity: 100% for the MRSA strains tested with growth and formation of magenta colored colonies within 24 hours on HardyCHROM™ MRSA.
- Specificity: 100% for MSSA strains which showed no growth after 48 hours.
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.
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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.
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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
§ 866.1700 Culture medium for antimicrobial susceptibility tests.
(a)
Identification. A culture medium for antimicrobial susceptibility tests is a device intended for medical purposes that consists of any medium capable of supporting the growth of many of the bacterial pathogens that are subject to antimicrobial susceptibility tests. The medium should be free of components known to be antagonistic to the common agents for which susceptibility tests are performed in the treatment of disease.(b)
Classification. Class II (performance standards).
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Hardy Diagnostics
510(k) Submission
510(k) Summary
MAY - 4 2011
Device Trade Name HardyCHROM™ MRSA
Intended Use
HardyCHROM™ MRSA is a selective and differential chromogenic medium recommended for the qualitative detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA infections in health care settings. The test is performed on anterior nares swabs from patients and healthcare workers to screen for MRSA colonization. HardyCHROM™ MRSA is not intended to diagnose MRSA infection nor to guide or monitor therapy for MRSA infections. Concomitant cultures are necessary to recover organisms for susceptibility testing or epidemiological typing. A negative result does not preclude MRSA nasal colonization.
079222
HardyCHROM™ MRSA is translucent and light amber in color Device Description and contains chromogens that release chromophores when cleaved by enzymes produced by methicillin resistant Staphylococcus aureus (MRSA) strains. Based on colony color, HardyCHROM™M MRSA allows for the reliable detection of most MRSA from clinical specimens in less than 24 hours based on the appearance of a pink/magenta colored colony. Non-MRSA strains are either inhibited by the addition of selective agents or utilize different chromogenic substrates in the media to produce different colored colonies. If none of the substrates are utilized, natural or white colored colonies will be present. If plates are negative for growth after 24 hours, it is recommended to re-incubate for an additional 24 hours.
Summary of Performance Data
Interference Studies
Substances that were expected to be associated with MRSA strains in a healthcare setting were evaluated for potential interference of the chromogenic reaction and growth of MRSA strains on HardyCHROM™ MRSA. To serve as a control for this portion of the study, growth was also evaluated on nonselective Trypticase Soy Agar with 5% Sheep Blood (Blood Agar) plates and a commercial chromogenic MRSA medium. Testing included commonly used nasal sprays, bacterial transport devices, mucin, and human blood. Isolates used in these studies included ATCC® control strains of MRSA (ATCC® 33591, ATCC® 43300) and ten clinical well characterized clinical MRSA isolates. The mucin study also included ten well characterized clinical MSSA isolates. The clinical isolates (challenge strains) were obtained from a private culture collection. All isolates were coagulase positive and were characterized by PBP2' and cefoxitin (30 ug) testing.
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Interference Study Results - Nasal Sprays
Commonly used nasal sprays that contain a concentration of 1% Phenylephrine Hydrochloride did show an minimal inhibitory affect for microbial growth on the nonselective Blood Agar plates, the HardyCHROM™ MRSA plates, and the commercial chromogenic MRSA medium. Nasal sprays that did not contain this ingredient showed no interference for growth or chromogenic reactions. The sensitivity and specificity criteria of >98% were met for the HardyCHROM™ MRSA plates as compared to the commercial chromogenic MRSA medium and Blood Agar plates.
Interference Study Results - Human Blood
Human blood could potentially be associated with MRSA strains in a healthcare setting and therefore was evaluated for potential interference of the chromogenic reaction and growth. Isolates used in this study included ATCC® control strains of MRSA (ATCC® 33591, ATCC 43300) and ten clinical well characterized clinical MRSA isolates. All strains were evaluated for growth and performance on HardyCHROM™ MRSA, a commercial chromogenic MRSA medium, and Blood Agar plates.
Results demonstrated that none of the MRSA strains were inhibited on the three types of media evaluated, and there was a 100% recovery rate for all strains after exposure to human blood. No discernible difference was observed between the growth and performance testing of HardyCHROM™ MRSA in comparison with nonselective blood agar plates and the commercial chromogenic MRSA medium.
Interference Study Results - Mucin
Nasal swabs containing mucous or mucin were evaluated determine if there was an effect on the chromogenic reaction and the growth of MRSA strains. Isolates used in this study included ATCC® control strains of MRSA (ATCC® 33591, ATCC® 43300), ten clinical well characterized clinical MRSA isolates and ten well characterized clinical MSSA isolates.
All of the strains were evaluated for growth and performance on HardyCHROM™ MRSA and Blood Agar plates. No discernible differences were noted in performance testing of the MRSA strains when compared to the growth on the blood agar plates. Colonies of the MRSA strains grown on HardyCHROM MRSA™ were typical for coloration and size. Counts were stable at 18 hours with no additional growth detected at 24 or 48 hours. All MSSA strains that were tested showed growth only on the blood agar plate and were completely inhibited at 24 and 48 hours on HardyCHROM MRSA™. The results of this study indicate that there is no inhibitory effect of mucin on growth and performance of HardyCHROM MRSA™ medium.
Interference Study Results – Transport Media
Various types of transport media expected to be associated with MRSA strains in a healthcare setting were evaluated for potential interference of the chromogenic reaction and growth. Isolates used in this study included ATCC® control strains of MRSA (ATCC® 33591. ATCC 43300) and ten clinical well characterized clinical MRSA isolates. All of the strains were evaluated for growth and performance on HardyCHROM™ MRSA, a commercial chromogenic MRSA medium, and Blood Agar plates. Testing included the following commonly used types transport media: Stuart's Liquid, Amies Liquid, Amies Liquid, Amies Gel, and Amies Charcoal. Each transport device tested contained rayon-tipped, plastic shaft swabs.
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Results demonstrated that none of the MRSA strains were inhibited on the three types of media evaluated, and there was a 100% recovery rate for all transport media devices tested. No discernible difference was observed between the growth and performance testing of HardyCHROM™ MRSA in comparison with nonselective blood agar plates and the commercial chromogenic MRSA medium.
Cross-Reactivity Study
Common types of nasal flora were evaluated for growth and performance on nonselective blood agar plates, HardyCHROM™ MRSA, and a commercial chromogenic MRSA medium. Fresh suspensions were prepared in Tryptic Soy Broth at concentrations of approximately 10 to the MRSA strains and 10 to10' for non-MRSA strains. 10ul of these suspensions was used to inoculate the media. A total of 121 strains were tested and included the following genera: Acinetobacter, Burkholderia, Candida, Corynebacterium, Enterococcus, Enterobacter, Escherichia, Klebsiella, Leuconostoc, Micrococcus, Moraxella, Neisseria, Proteus, Pseudomonas, Streptococcus and Staphylococcus. Staphylococcus strains included MRSA, MSSA, and 20 different species of coagulase negative staphylococci (including methicillin resistant Staphylococcus epidermidis). HardyCHROM™M MRSA and the commercial chromogenic MRSA medium showed no discernible difference for performance and growth.
Acceptance reproducibility rate of >99% for both inter-lot and overall testing intervals was achieved with the HardyCHROM™ MRSA media. On HardyCHROM™ MRSA medium all of the MRSA strains tested were detected with 24 hours following aerobic incubation at 35-37℃ due to their unique pink to magenta colony coloration. Non-MRSA strains that were methicillin resistant either did not grow (i.e. methicillin-resistant Staphylococcus enidermidis) or produced blue-colored colonies (S. intermedius) that were easily discernible from MRSA strains based on colony color.
Corynebacterium jeikeium had breakthrough growth in the first quadrant at 24 hours with development of a dark purple colored film. Upon further incubation, small dark purple colored colonies were seen at 48 hours. Other strains of bacteria and yeast were inhibited by the selective agents included in the media.
Recovery Study (Limit of Detection (LoD))
On HardyCHROM™ MRSA medium, MRSA strains tested were detected beginning at 16 hours with final counts being reported at 24 hours following aerobic incubation at 35°C. Pink to magenta colonies were detected on all dilutions at 16 hours and colony counts were stable from 21 to 24 hours with no increase in the number of colonies counted. All dilutions plated showed typical pink to magenta colony coloration. There was no significant difference in counts noted between the two observers.
Staphylococcus aureus ATCC® 43300 resulted in a 67.6% recovery when present at 10€ concentration and Staphylococcus aureus ATCC® 33591 resulted in a 34.6% recovery at the same dilution. At 10', there was 80% recovery and 52.3% recovery respectively. At 10' there was no discernible difference in recovery.
Mixed Infection Study
Suspensions of the non-MRSA organisms (Staphylococcus aureus MSSA ATCC® 25923 and E. coli ATCC® 25922) were prepared at 10° and 10° and mixed with suspensions of the MRSA strains (Staphylococcus aureus MRSA strains (ATCC® 33591 and 43300)) at the detection limit
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concentration (103 CFU/mL) and plated in duplicate on Blood Agar and on HardyCHROM™ MRSA. On HardyCHROM™ MRSA medium, the MRSA strains tested were detected beginning at 16 hours with final counts being reported at 24 hours following aerobic incubation at 35°C. Pink to magenta colonies were detected on all dilutions at 16 hours and colony counts were stable at 21 to 24 hours with no increase in the number of colony forming units (CFU) counted. All dilutions plated showed typical pink to magenta colony coloration and colony morphology was consistent with the MRSA strains. No breakthrough was noted of any of the non-MRSA strains. Plates were held for 48 hours and there was no change in CFU of MRSA strains nor was there any breakthrough of non-MRSA.
Incubation Study
When compared to traditional culture, 127 of 132 positive MRSA cultures (96.2%) were detected on HardyCHROM™ MRSA at less than or equal to 24 hours. The remaining five MRSA isolates were detected at approximately 48 hours. All testing (clinical and in-house testing) was incubated aerobically (non-CO2) at 35 to 37 degrees C.
Reproducibility Study with Characterized MRSA & MSSA strains
Reproducibility testing of HardyCHROM™ MRSA was conducted with twenty wellcharacterized test strains (fifteen MRSA strains that included Pulse-Field Gel Electrophoresis (PFGE) types USA100, USA200, USA300-0114, USA400, USA500, USA600, USA700, USA800, USA1000, USA1100, five a dditional MRSA strains that are representative of prevalent HA-MRSA and CA-MRSA. and five MSSA (including Hypervirulent MSSA (NRS72) were selected from the most medically important S. aureus lineages'->). SF8300 is a wound isolate of pulse-field type USA300-0114, a subtype implicated in severe disease and in numerous outbreaks (1). All of the characterized test strains were obtained from the University of San Francisco and DNA restriction patterns were determined by pulsed-field gel electrophoresis. (6)
The fifteen strains of MRSA were tested using a suspension containing approximately 10 to 10° CFU/ml and the five strains of MSSA were tested at a concentration of approximately 10° to 10'. Ten ul of these suspensions were inoculated onto HardyCHROM™ MRSA. The performance of the HardyCHROM™ MRSA at recovery rate (LoD) was not been evaluated.
Three different lots of HardyCHROM™ MRSA plates were tested to determine that the HardyCHROM™ MRSA plates reliably detected MRSA strains across different lots at different time intervals. A commercial chromogenic MRSA medium was also evaluated with the same strains and served as a performance standard.
Acceptance reproducibility rate of 100% for both inter-lot and overall testing intervals was achieved with the HardyCHROM™ MRSA plates media. All of the characterized MRSA strains showed growth and pink to magenta colony coloration within 24 hours following aerobic (non-CO-) incubation at 35°-37°C. All of the MSSA strains were inhibited with no growth evident after 24 and 48 hours of aerobic incubation at 35°C. No discernible difference was observed between the performance testing of HardyCHROM™ MRSA in comparison with the commercial chromogenic MRSA medium.
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CLINICAL STUDIES
Performance Data
HardyCHROM™ MRSA plates were evaluated at three geographically diverse hospitals and clinics using surveillance specimens of anterior nasal swab samples. A total of four hundred forty-three (443) samples were evaluated overall for this study. Positive and negative controls were tested each day of use. Clinical study sites reported the use of rayon tipped plastic shaft Stuart's gel without charcoal, Liquid Stuarts, Amies Charcoal. One test site reported the use of nylon flocked Amies Eswabs.
For the purpose of this study one nasal specimen swab was used to inoculate a Blood Agar plate first followed by a HardyCHROM™ MRSA plate. A second swab from the same patient was used to inoculate a plate of commercial chromogenic MRSA medium. All of the plates were incubated following standard lab procedures for the Blood Agar and the manufacturer's instructions for the commercial chromogenic MRSA medium and for HardyCHROM™ MRSA plates. Both types of chromogenic plates were incubated aerobically at 35°-37°C (non-CO2) and were read at both 24 and 48 hours of incubation.
Results from HardyCHROM™ MRSA plates after 24 hours of incubation were compared to the traditional culture method of Trypticase Soy Agar with 5% Sheep Blood (Blood Agar). With the Blood Agar plates, colonies suspected to be S. aureus were confirmed with a StaphTEX latex agglutination test. Further testing to characterize colonies of MRSA was performed using a PBP2' test for the detection of penicillin-binding protein 2a and antibiotic disk diffusion methods using an oxacillin disk (1ug) and also a cefoxitin disk (30μg). Disk susceptibility testing was performed and interpreted according to CLSI guidelines contained in M100-S20. HardyCHROM™ MRSA plates were also compared with a commercial chromogenic MRSA medium for overall evaluation of growth and chromogenic performance.
Quality Control
Ouality control was performed by each of the three testing sites on receipt of each shipment of the medium and on each day of use. Fresh suspensions of Staphylococcus aureus (MRSA) ATCC® 43300 and Staphylococcus aureus (MSSA) ATCC® 25923 were prepared in Tryptic Sov Broth at concentrations of approximately 10 to10 for the MRSA strain and 10° to10' for MSSA. 10ul of these suspensions were used to inoculate HardyCHROM™ plates. Plates were incubated and examined for 24 and 48 hours for growth of the MRSA strain and inhibition of the MSSA strain. All OC results testing results provided expected reactions at each of the three testing sites on each day tested.
Product performance is summarized below.
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| Table 1: HardyCHROM™ MRSA vs. Traditional Culture 24 hours | |
|---|---|
| ------------------------------------------------------------ | -- |
| | Traditional Culture
24 hours | | | Percent Agreement | |
|------------------------------|---------------------------------|-----------|-------|------------------------------------|----------------------|
| HardyCHROM™ MRSA
24 hours | MRSA | Non-MRSA* | Total | | |
| MRSA | 126 | 1** | 127 | Positive Percent Agreement - 93.3% | (95% CI 89.6-98.4%) |
| Non-MRSA* | 9 | 307 | 316 | Negative Percent Agreement - 99.7% | (95% CI 98.9 - 100%) |
| Total | 135 | 308 | 443 | | |
*Organisms producing other types of non-mecA resistance were not evaluated on this medium (e.g. MOD-SA and BORSA).
**One MRSA isolate was detected on HardyCHROM™ MRSA that was not detected by traditional culture. Nine MRSA isolates were detected by traditional culture methods, but did not grow on HardyCHROM™ MRSA. Discrepant results were confirmed as MRSA positive by cefoxitin disk diffusion.
Table 2: HardyCHROMTM MRSA vs. Traditional Culture 48 hours
| | Traditional Culture
48 hours | | | Percent Agreement |
|------------------------------|---------------------------------|-----------|-------|------------------------------------------------------------|
| HardyCHROM™ MRSA
48 hours | MRSA | Non-MRSA* | Total | |
| MRSA | 131 | 1** | 132 | Positive Percent Agreement - 97.0%
(95% CI 89.6-98.5%) |
| Non-MRSA* | 4 | 307 | 311 | Negative Percent Agreement - 99.7%
(95% CI 98.9 - 100%) |
| Total | 135 | 308 | 443 | |
*Organisms producing other types of non-mecA resistance were not evaluated on this medium (e.g. MOD-SA and BORSA).
** One MRSA isolate was detected on HardyCHROM™ MRSA that was not detected by traditional culture. Four MRSA isolates were detected by traditional culture methods, but did not grow on HardyCHROM™ MRSA. Discrepant results were confirmed as MRSA positive by cefoxitin disk diffusion.
Table 3: HardyCHROM™ MRSA vs. Commercial Chromogenic MRSA Medium 24 hours
| | Commercial Chromogenic Medium
24 hours | | | Percent Agreement |
|--------------------------------------------|-------------------------------------------|-----------|-------|-------------------------------------------------------------|
| HardyCHROM TM MRSA
24 hours | MRSA | Non-MRSA* | Total | |
| MRSA | 118 | 8** | 126 | Positive Percent Agreement – 98.3%
(95% CI 97.5 – 99.3%) |
| Non-MRSA* | 2* | 315 | 317 | Negative Percent Agreement – 97.5%
(95% CI 98.9 – 100%) |
| Total | 120 | 323 | 443 | |
*Organisms producing other types of non-mecA resistance were not evaluated on this medium (e.g. MOD-SA and BORSA).
**Eight MRSA isolates were detected on HardyCHROM™ MRSA that were not detected on the commercial chromogenic MRSA medium. Two MRSA isolates were detected on the commercial chromogenic MRSA medium, but did not grow on HardyCHROM™ MRSA. Discrepant results were confirmed as MRSA positive by cefoxitin disk diffusion.
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Table 4: HardyCHROMTM MRSA vs. Commercial Chromogenic MRSA Medium 48 hours
| | | Commercial Chromogenic MRSA Medium
48 hours | | | Percent Agreement |
|-------------------------------|------|------------------------------------------------|-------|--|-------------------------------------------------------------|
| HardyCHROMTM MRSA
48 hours | MRSA | Non-MRSA* | Total | | |
| MRSA | 122 | 10** | 132 | | Positive Percent Agreement - 98.4%
(95% CI 97.5 - 99.3%) |
| Non-MRSA* | 2 | 309 | 311 | | Negative Percent Agreement - 96.9%
(95% CI 89.6 - 98.4%) |
| Total | 124 | 319 | 443 | | |
*Organisms producing other types of non-mecA resistance were not evaluated on this medium (e.g. MOD-SA and BORSA).
**Ten MRSA isolates were detected on HardyCHROM™ MRSA that did not grow on the commercial chromogenic MRSA medium. Two MRSA isolates were detected on the commercial chromogenic MRSA medium, but did not grow on HardyCHROM™ MRSA. Discrepant results were confirmed as MRSA positive by cefoxitin disk diffusion.
Table 5: Summary of Agreement
| MRSA | Non-MRSA* | |
|---|---|---|
| HardyCHROM TM MRSA vs. | ||
| Traditional Culture | ||
| 24 hours | 93.3% | |
| (126/135) | ||
| (95% CI 89.6-98.4%) | 99.7% | |
| (307/308) | ||
| (95% CI 98.9 - 100%) | ||
| HardyCHROM TM MRSA vs. | ||
| Traditional Culture | ||
| 48 hours | 97.0% | |
| (131/135) | ||
| 95% CI 89.6-98.5% | 99.7% | |
| (307/308) | ||
| 95% CI 98.9 - 100% | ||
| HardyCHROM TM MRSA vs. | ||
| Commercial Chromogenic MRSA Medium | ||
| 24 hours | 98.3% | |
| (118/120) | ||
| 95% CI 97.5 - 99.3% | 97.5% | |
| (315/323) | ||
| 95% CI 89.6-98.4% | ||
| HardyCHROM TM MRSA vs. Commercial | ||
| Chromogenic MRSA Medium | ||
| 48 hours | 98.4% | |
| (122/124) | ||
| 95% CI 97.5 - 99.3% | 96.9% | |
| (309/319) | ||
| 95% CI 89.6-98.4% |
*Organisms producing other types of non-mecA resistance were not evaluated on this medium (e.g. MOD-SA and BORSA).
Performance Compared to PBP2', Oxacillin, and Cefoxitin Disk Diffusion
HardyCHROM™ MRSA was also compared to other laboratory test methods commonly used to identify MRSA strains. In this study each clinical testing site evaluated pink/magenta colored colonies growing on the HardyCHROM™ MRSA plates with PBP2' Latex agglutination. Cefoxitin disk (30μg) and oxacillin disk (1μg) diffusion testing was performed to confirm results. Cefoxitin and oxacillin disk susceptibility was performed and interpreted according to CLSI M100-20. Interpretive zone sizes for oxacillin are ≥13 (Susceptible), 11-12 (Indeterminate), and ≤10 (Resistant). Zone sizes for cefoxitin are ≥22 (Susceptible) and ≤21 (Resistant). No differences in the interpretation of susceptibility/resistance were noted between the two disk types.
Sensitivity and specificity compared to these additional methods are shown in Table 6 - 11.
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Summary of HardyCHROM™ MRSA with Other Detection Methods
Table 6: HardyCHROM™M MRSA vs. PBP2* 24 hours
| | PBP2' Latex Agglutination
24 hours | | | Percent Agreement |
|------------------------------|---------------------------------------|-----------|-------|-------------------------------------------------------------|
| HardyCHROM™ MRSA
24 hours | MRSA | Non-MRSA* | Total | |
| MRSA | 126 | 1** | 127 | Positive Percent Agreement - 93.3%
(95% CI 89.6 – 98.4%) |
| Non-MRSA* | 9 | 307 | 316 | Negative Percent Agreement - 99.7%
(95% CI 98.9 – 100%) |
| Total | 135 | 308 | 443 | |
*Organisms producing other types of non-mecA resistance were not evaluated on this medium (e.g. MOD-SA and BORSA).
** 1/1 Blood Agar Plate negative specimen was confirmed as MRSA positive by cefoxitin disk diffusion.
| | PBP2' Latex Agglutination
48 hours | | | Percent Agreement |
|------------------------------|---------------------------------------|-----------|-------|------------------------------------------------------------|
| HardyCHROM™ MRSA
48 hours | MRSA | Non-MRSA* | Total | |
| MRSA | 131 | 1** | 132 | Positive Percent Agreement - 97.0%
(95% CI 89.6-98.5%) |
| Non-MRSA* | 4 | 307 | 311 | Negative Percent Agreement - 99.7%
(95% CI 98.9 - 100%) |
| Total | 135 | 308 | 443 | |
Table 7: HardyCHROM™ MRSA vs. PBP2' 48 hours
*Organisms producing other types of non-mecA resistance were not evaluated on this medium (e.g. MOD-SA and BORSA).
** 1/1 Blood Agar Plate negative specimen was confirmed as MRSA positive by cefoxitin disk diffusion.
Table 8: HardyCHROM™ MRSA vs. Cefoxitin Disk 30ug 24 hours
| | Cefoxitin 30µg
24 hours | | | Percent Agreement |
|--------------------------------------------|----------------------------|-----------|-------|-------------------------------------------------------------|
| HardyCHROM TM MRSA
24 hours | MRSA | Non-MRSA* | Total | |
| MRSA | 126 | 1** | 127 | Positive Percent Agreement - 93.3%
(95% CI 89.6 – 98.4%) |
| Non-MRSA* | 9 | 307 | 316 | Negative Percent Agreement – 99.7%
(95% CI 98.9 – 100%) |
| Total | 135 | 308 | 443 | |
*Organisms producing other types of non-mecA resistance were not evaluated on this medium (e.g. MOD-SA and BORSA).
** 1/1 Blood Agar Plate negative specimen was confirmed as MRSA positive by cefoxitin disk diffusion.
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HardyCHROM™ MRSA
48 hours
MRSA
Non-MRSA *
Total
Table 9: HardyCHROMTM MRSA vs. Cefoxitin 30ug Disk 48 hours
MRSA
131
4
135
Cefoxitin 30pg
307
308
48 hours Percent Agreement Non-MRSA* Total Positive Percent Agreement - 97.0% (95% CI 89.6-98.5%) | ** 132
311
443
Negative Percent Agreement - 99.7% (95% CI 98.9 - 100%)
*Organisms producing other types of non-mecA resistance were not evaluated on this medium (e.g. MOD-SA and BORSA).
** 1/1 Blood Agar Plate negative specimen was confirmed as MRSA positive by cefoxitin disk diffusion.
Table 10: HardyCHROMTM MRSA vs. Oxacillin Disk 1ug 24 hours
| | Oxacillin 1µg
24 hours | | | Percent Agreement |
|------------------------------|---------------------------|-----------|-------|-------------------------------------------------------------|
| HardyCHROM™ MRSA
24 hours | MRSA | Non-MRSA* | Total | |
| MRSA | 126 | 1** | 127 | Positive Percent Agreement - 93.3%
(95% CI 89.6 – 98.4%) |
| Non-MRSA* | 9 | 307 | 316 | Negative Percent Agreement – 99.7%
(95% CI 98.9 – 100%) |
| Total | 135 | 308 | 443 | |
*Organisms producing other types of non-mecA resistance were not evaluated on this medium (e.g. MOD-SA and BORSA).
** 1/1 Blood Agar Plate negative specimen was confirmed as MRSA positive by cefoxitin disk diffusion.
Table 11: HardyCHROM™ MRSA vs. Oxacillin Disk 1ug 48 hours
| | Oxacillin Disk 1ug
48 hours | | | Percent Agreement |
|------------------------------|--------------------------------|-----------|-------|------------------------------------------------------------|
| HardyCHROM™ MRSA
48 hours | MRSA | Non-MRSA* | Total | |
| MRSA | 131 | 1** | 132 | Positive Percent Agreement - 97.0%
(95% CI 89.6-98.5%) |
| Non-MRSA* | 4 | 307 | 311 | Negative Percent Agreement - 99.7%
(95% CI 98.9 - 100%) |
| Total | 135 | 308 | 443 | |
*Organisms producing other types of non-mecA resistance were not evaluated on this medium (e.g. MOD-SA and BORSA).
** 1/1 Blood Agar Plate negative specimen was confirmed as MRSA positive by cefoxitin disk diffusion.
Reproducibility Testing in Clinical Laboratory Setting
Testing of HardyCHROM™ MRSA was evaluated at all three testing sites for three days in triplicate by three different operators using three different lots of media. The challenge strains were clinical isolates obtained from a private culture collection and included ten well characterized MRSA strains and ten well characterized MSSA strains. All isolates were coagulase positive and were characterized by PBP2' and cefoxitin testing. All of the isolates showed expected results.
Fresh suspensions of the well-characterized clinical strains were prepared in Tryptic Soy Broth at concentrations of approximately 10 to10 for the MRSA strains and 10° to10' for
9
MSSA strains. 10ul of these suspensions were used to inoculate HardyCHROM™ plates. The performance of the HardyCHROM™ MRSA at recovery rate (LoD) was not been evaluated.
A reproducibility rate of 100% for both inter-lot and overall testing intervals was achieved with the HardyCHROM™ MRSA media. At each clinical trial site, sensitivity was 100% for the MRSA strains tested with growth and formation of magenta colored colonies within 24 hours on HardyCHROM™ MRSA following aerobic (non-CO2) incubation at 35°-37°C. The specificity was 100% for MSSA strains which showed no growth after 48 hours of aerobic (non-CO2) incubation at 35°-37°C.
No discernible differences were observed between performance testing of HardyCHROM™ MRSA in comparison with the commercial chromogenic MRSA medium.
Quality Control Results
Quality control results for both inter-lot and daily testing achieved a 100% acceptance rate with the HardyCHROM™ MRSA medium at each individual site and across all three clinical test sites. Quality control testing was performed upon receipt of the medium and on each day of testing. Fresh suspensions of Staphylococcus aureus (MRSA) ATCC® 43300 and Staphylococcus aureus (MSSA) ATCC® 25923 were prepared in Tryptic Soy Broth at concentrations of approximately 10° to 10° for the MRSA strain and 10° to10' for MSSA. 10μ1 of these suspensions were used to inoculate HardyCHROM™ plates. The control strain, Staphylococcus aureus (MRSA) ATCC® 43300 produced growth with typical magenta colony coloration within 24 hours on HardyCHROM™ MRSA following aerobic (non-CO2) incubation at 35°-37° C. The control strain Staphylococcus aureus (MSSA) ATCC® 25923 was inhibited and showed no growth after 48 hours aerobic (non-CO2) incubation at 35°-37° C.
Statement of Efficacy and Safety
HardyCHROM™ MRSA was tested and compared to traditional culture identification and susceptibility methods as well as a commercial chromogenic MRSA medium. HardyCHROM™ MRSA demonstrated 93.3% agreement to traditional culture at 24 hours and 97.0% agreement at 48 hours for mecA mediated MRSA. Agreement was 99.7% for non-MRSA at both 24 and 48 hours. When compared to the commercial chromogenic MRSA medium, HardyCHROM™ MRSA demonstrated 98.3% agreement at 24 hours and 98.4% at 48 hours for mecA mediated MRSA and 97.5% agreement at 24 hours and 96.9% agreement for non-MRSA at 48 hours.
Agreement with PBP2', cefoxitin (30μg) and oxacillin (1μg) disk testing was 93.3% at 24 hours and 97.0% at 48 hours for mecA mediated MRSA. Percent agreement was 99.7% for non-MRSA at both 24 and 48 hours.
Hardy Diagnostics confirms that any and all non-confidential data provided in this submission may be released upon request.
Any information available on the safety of this device will be made available to interested persons upon request.
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References:
-
- Diep B.A., Stone, GG, Basuino, L, et al. 2008. The arginine catabolic mobile element and staphylococcal chromosomal cassette mec linkage: convergence of virulence and resistance in the USA300 clone of methicillin-resistant Staphylococcus aureus. JID 197:1523-1530.
-
- Wang R, Braughton KR, Kretschemer D, et al. 2007. Identification of novel cytolytic peptides as key virulence determinants for community-associated MRSA. Nat. Mcd 13:1510-1514
-
- Aguiar-Alves F, Medeiros F, Fernandes O, et al. 2006. New Staphylococcus aureus Genotyping Method Based on Exotoxin (set) Genes. J Clin Micro. 44:2728-2732.
-
- Li M, Diep BA, Villaruz AE, et al. 2009. Evolution of virulence in epidemic community- associated methicillin-resistant Staphylococcus aureus. PNAS 106:5883-5888
-
- Li M, Cheung YC, Hu J, et al. 2010. Comparative analysis of virulence and toxin expression of global community-associated methicillin-resistant Staphylococcus aureus strains. JID 202(12):1866-1876.
-
- Tenover FC, Arbeit RD, Goering RV et al. 1995. Interpreting chromosomal DNA restriction patterns produced by pulsed-field gel electrophoresis: criteria for bacterial strain typing. J Clin Microbiol 33:2233-9
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Image /page/11/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Hardy Diagnostics c/o Ms. Rene Clasen Director of Technical Services/R&D 1430 West McCoy Lane Santa Maria, CA 93455
MAY - 4 2011
Re: K102922
Trade/Device Name: HardyCHROM™ MRSA Regulation Number: 21 CFR 866.1700 : Regulation Name: Culture medium for antimicrobial susceptibility tests. Regulatory Class: Class II Product Code: JSO Dated: April 26, 2011 Received: April 27, 2011
Dear Ms. Clasen
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.
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
12
Page 2 - Ms. Rene Clasen
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 Vitro 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 vours.
Vally a Hoyns
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
Enclosure
13
Indication for Use Statement
510(k) Number (if known): K102922
Device Name: HardyCHROM™ MRSA
Indication for Use:
HardyCHROM™ MRSA is a selective and differential chromogenic medium recommended for the qualitative detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA infections in health care settings. The test is performed on anterior nares swabs from patients and healthcare workers to screen for MRSA colonization. HardyCHROM™ MRSA is not intended to diagnose MRSA infection nor to guide or monitor therapy for MRSA infections. Concomitant cultures are necessary for susceptibility testing or epidemiological typing. A negative result does not preclude MRSA nasal colonization.
Prescription Use V (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Fredalie L. Pooly
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K102922