(260 days)
Not Found
No
The device description details a biochemical identification system that uses a numerical profile generated from color reactions and an electronic codebook for identification. There is no mention of AI or ML algorithms being used for image processing, pattern recognition, or complex data analysis beyond a lookup table or rule-based system.
No.
The device is intended for the identification of frequently isolated aerobic gram-positive bacteria from clinical specimens, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is intended for the identification of frequently isolated aerobic gram-positive bacteria from clinical specimens, which is a diagnostic purpose.
No
The device description clearly outlines physical components like the BBLCRYSTAL GP panel assembly (base and lid), dehydrated substrates, and inoculum fluid, which are integral to the device's function. While there is a software component (Electronic Codebook), it is used in conjunction with and relies on the results generated by the physical components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "identification of frequently isolated aerobic gram-positive bacteria from clinical specimens." This is a classic definition of an in vitro diagnostic device, as it's used to analyze samples taken from the human body (clinical specimens) to provide information for diagnosis or treatment.
- Indications for Use: The indications for use further clarify that it's used when these organisms "have been isolated in pure culture from clinical specimens in a clinical laboratory, and identification of the microorganisms is desired." This reinforces its use in a clinical setting for diagnostic purposes.
- Device Description: The description details a system that uses biochemical, chromogenic, and fluorogenic substrates to react with a pure culture suspension from a clinical specimen. The results of these reactions are then interpreted to identify the microorganism. This process of analyzing a biological sample outside the body to gain diagnostic information is the core function of an IVD.
- Clinical Laboratory Setting: The intended user is a "clinical laboratory," which is where IVD testing is performed.
- Performance Studies: The inclusion of performance studies like "Clinical Correlation" and "Reproducibility" with metrics like "Correctly identified," "Incorrectly identified," and "Reproducibility" are standard for demonstrating the performance of an IVD.
- Predicate Devices: The listing of predicate devices (API Staph, API 20 Strep, API Coryne) which are known IVD systems for bacterial identification further supports that this device falls into the same category.
In summary, the BBLCRYSTAL™ Gram Positive (GP) Identification (ID) System meets all the key criteria of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
INTENDED USE: The BBLCRYSTAL™ Gram Positive (GP) Identification (ID) System is a miniaturized identification method employing modified conventional, fluorogenic, and chromogenic substrates. It is intended for the identification of frequently isolated aerobic gram-positive bacteria from clinical specimens.
INDICATIONS FOR USE: Use of the BBLCRYSTAL™ Gram Positive Identification System is indicated when the aerobic gram-positive organisms described in the attached table have been isolated in pure culture from clinical specimens in a clinical laboratory, and identification of the microorganisms is desired.
Product codes
Not Found
Device Description
The main component of the BBLCRYSTAL™ GP ID System is the BBLCRYSTAL GP panel assembly, consisting of the CRYSTAL base and lid. The BBLCRYSTAL lid consists of 29 dehydrated biochemical/chromogenic/ fluorogenic substrates and one fluorogenic negative control, on the ends of plastic prongs. The CRYSTAL base consists of 30 matching wells; its design allows inoculation of all 30 wells in a single step by pouring the suspension of pure culture into the target area and tilting the base. The test inoculum rehydrates the dried substrates and initiates test reactions.
The pure culture suspension is prepared by picking several small colonies of the same morphology from media such as Trypticase® Soy Agar with 5% Sheep Blood or Columbia Agar with 5% Sheep Blood, or alternatively selective media such as Phenylethyl Alcolol Agar with 5% Sheep Blood or Columbia CNA Agar with 5% Sheep Blood. A standardized suspension of this culture is prepared in the BBLCRYSTAL™ ANR, GP, RGP, N/H ID Inoculum Fluid provided. The suspension is added to the target area of the panel base, which the use then rocks back and forth to inoculate all the wells contained in the base.
After the base/lid assembly has been incubated for 4 hours at 35-37°C, the assembly is placed on the BBLCRYSTAL Panel Viewer and the color reactions are visually compared to the BBLCRYSTAL GP Color Chart provided. Each reaction is scored as a positive (+) or negative (-) and recorded on the BBLCRYSTAL GP Report Form.
After all results are read, a 10-digit numerical profile is calculated by assigning a value of 4, 2, or 1 to each positive reaction. (Negative reactions are scored as "O".) The values for each column are then added together to obtain the 10 digit Profile Number.
The BBLCRYSTAL ID System Electronic Codebook is loaded into the user's PC and the appropriate database is selected. Then the Profile Number and results of any off-line tests are entered, and the Codebook gives one of the following three results:
- (a) a definitive ID;
- (b) a tie between two or more species; or
- no ID possible with data submitted. (c)
In the case of a definitive ID or a tie between two or more potential ID's, the user can access the statistics for that ID as well as background information for the species identified.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Clinical Correlation: In a study conducted at four clinical laboratories, the performance of the BBLCRYSTAL Gram Positive ID System was evaluated against a combination of the API Staph, API 20 Strep, and API Coryne Identification Systems, and conventional methodologies. Fresh, routine isolates arriving in the clinical laboratory, as well as previously identified isolates of the clinical trial sites" choice were utilized in the study. A total of 735 gram positive aerobic isolates were tested; 90% (668/735) of these isolates were correctly identified (including supplemental testing) using the BBLCRYSTAL™ GP ID System; 7.6% (56/735) were incorrectly identified; and 1.5% (11/735) vielded a "No Identification" result.
Reproducibility: At the same four clinical laboratories, reproducibility of the BBLCRYSTAL™ GP ID System was established by testing ten (10) Quality Control strains in triplicate on three days. Evaluations were performed of individual and overall reproducibility of substrate reactions, of QC organism reactions, and of interand intra-laboratory reproducibility.
Overall reproducibility was calculated as 96.7%. Reproducibility of individual substrate reactions ranged from 79.2 to 100%; individual QC organism reaction reproducibility ranged from 91.4 to 99.8%; and individual site reproducibility from 95.5 to 97.8%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.2660 Microorganism differentiation and identification device.
(a)
Identification. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of 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
KA61968
FEB - 4 1997
May 17, 1996
SUMMARY OF SAFETY AND EFFECTIVENESS
SUBMITTED BY:
Virginia C. Weinknecht Becton Dickinson Microbiology Systems P O Box 243 Cockevsville, MD 21030-0243
NAME OF DEVICE:
| Trade Name: | BBLCRYSTAL™ Gram Positive ID System |
|---|---|
| Common Name/Description: | Miniaturized Microorganism ID System |
| Classification Name: | Microbiology - Discs, Strips, and Reagents, |
| Microorganism Differentiation |
PREDICATE DEVICES:
BioMerieux Vitek, Inc., API Staph (K813614) BioMerieux Vitek, Inc., API 20 Strep (K813610) BioMerieux Vitek, Inc., API Coryne (K910304)
DEVICE DESCRIPTION:
INTENDED USE: The BBLCRYSTAL™ Gram Positive (GP) Identification (ID) System is a miniaturized identification method employing modified conventional, fluorogenic, and chromogenic substrates. It is intended for the identification of frequently isolated aerobic gram-positive bacteria from clinical specimens.
INDICATIONS FOR USE: Use of the BBLCRYSTAL™ Gram Positive Identification System is indicated when the aerobic gram-positive organisms described in the attached table have been isolated in pure culture from clinical specimens in a clinical laboratory, and identification of the microorganisms is desired.
1
TABLE B-I: Taxa List for BBLCRYSTAL™ Gram Positive Identification System
Actinomyces pyogenes Aarococcus species includes A. urinee and A. viridans) Aarococcus urinae Aarococcus viridans Alfoiococcus otitidis Arcanobacterium haemolyticum
Bacillus brevis Bacillus cereus Bacillus circulans Bacillus coaculans Recilius lichaniformis Bacillus megatarium Becillus pumilus Bacillus species lincludes B. brevis, B. circulans, B. coagulans, B. licheniformis, B. megaterium, B. pumilus and B. sphaericus, P. alvei, P. macerans) Bacillus sphaericus Bacillus subtilis
Corvnebacterium aquaticum Corvnebacterium bovis Corvnebectarium diotheries linctudes C. dintharies sea arevis. C. diptheriee ssp mitis and C. diptheriae sap intermedius Corynabacterium genitalium Corvnebacterium jelkalum Corynebacterium kutscheri Corynebecterium propinguum Corynebacterium pseudodiotheriticum Corvnebectarium pseudogenitalium Corvnebacterium pseudotuberculosis Corynebacterium renele group Corynebacterium species (includes C. aquaticum, C. bovis, C. kutacheri, C. propinquum, c. psaudodiphthariticum, C. pseudotuberculosis, C. renale group, C. striatum and C. ulcerans) Corvnebacterium striatum Corvnebacterium ulcerans Enterococcus avium
Enterococcus casselifievus/gallinerum Enterocuccus durans Enterococcus faccall: Enterococcus faecium Enterococcus hime Enterococcus raffinosus Enterocuccus solitanus Ervsioelothrix rhusiopathias
Gardnerella vaginalis Gemells hasmolysans Gemella morbillorum Gamella species (includes G. haemolysans, and G. morbillorum) Globicatelle sanguis
Helcococcus kunzil
Lactococcus garviese Lactococcus lectis sep cremoris Lactococcus lectis sap hordnied Lactococcus lectis sap lactis Lactococcus reffinoloctis Lactococcus spacies lincludes L. lactis sao cremoris. L. lactis sso hordnise. I., loctis sap lactis and L. reffinolactis) Lauconostoc citreum Leuconostoc lactis Leuconostoc mesenteroides ssp mesenteroides Leuconostoc psaudomesenteroides Leuconostoc species (includes L. citreum, L. lectis. L. mesenteroides sap mezenteroides and L. psaudomesenteroides Listeria gravi Listeria ivanovii sso ivanovii Listeria monocytogenes Listeria murravi
Micrococcus kristinae Micrococcus luteus Micrococcus Iylee Micrococcus roseus Micrococcus sedentarius Micrococcus species lincludes M. kristinae, M. lutous. M. M. Mee, M. roseus, M. sedentarius)
Oerskovia species lincludes O. turbate, and O. xanthineolytical
Peonibacillus alvai Peonibacitus mecarans Pediococcus demnasus Pediococcus pervukis Pediococcus pentoseceus Pediococcus species (includes P.demnosus, P. pervulus, and P. pentosecous)
Rhodococcus equi Rothia dentocariosa
Staphylococcus aurous Staphylococcus suricularis Staphylococcus capitis lincludes S. capitis ssp capitis and S. capitis sup ureolyticus) Staphylococcus capras Staphylococcus camosus Staphylococcus cohnii lincludes S. cohnii seo cohnii and S. cohnii sap ures/vticum) Staphylococcus cohnil sap cohnii Staphylococcus cohnil sep urealyticum Staphylococcus epidermidia Staphylococcus equonim Staphylococcus felis Staphylococcus gallinerum Staphylococcus heemolyticus Staph viococcus hominis Staphylococcus intermedius
Staphylococcus kloosii Staphylococcus lantus Staphylococcus lugdunensis Staphylococcus pasteuri Staphylococcus seccharolyticus Staphylococcus saprophyticus Staphylococcus schleiferi (includes S. schleiferi ssp cagulans and S. schleiferi ssp schleiferi Staphylococcus sciuri Staphylococcus simulans Staphylococcus vitulus Staphylococcus werner Staphylococcus xylosus Stometococcus muciloginosus Streptococcus acidominimus Streptococcus agalecties Streptococcus anginosus Streptococcus bovis lincludes S. bovis I and S. bovis II) Streptococcus constellatus Streptococcus cricetus Streptococcus crists Streptococcus dvegalacties Streptococcus equi lincludes S. equi sap equi and S. equi ssp zooepidemicus) Streptococcus equi ssp equi Streptococcus equi ssp zooepidemicus Streatacaccus equinus Streptococcus gordonii Streptococcus internedius Streptococcus milleri group lincludes S. anginosus, S. constellatus and S. intermedius) Streptococcus mitis Streptococcus mitis group (includes S. mitis and S. oralis) Streptococcus mutans Streptococcus mutans group lincludes S. cricetus, S. mutans and S. sobrinus) Streptococcus oralis Straptococcus parasanguis Streptococcus pneumonies Streptococcus porcinus Streptococcus pyogenes Streptococcus salvanus Streptococcus saliverius group (includes S. saliverius and S. vastibularis) Streptococcus sanguis Streptococcus sanguis group lincludes S. crista, S. gordonii, S. perasenguis and S. sanguis) Streptococcus sobrinus Streptococcus uberis Streptoccus vestibularis
Turicella otitidis
' These taxa have