(39 days)
No
The device uses a biochemical reaction panel and a numerical profile lookup in an electronic codebook, which is a deterministic algorithm, not AI/ML.
No
The device is an in vitro diagnostic (IVD) system intended for the identification of microorganisms from clinical specimens, not for direct therapeutic intervention on a patient.
Yes
The device is intended for the identification of frequently isolated Neisseria and Haemophilus, and other fastidious bacteria from clinical specimens, which directly supports diagnosis by identifying the causative agent of a disease.
No
The device description clearly outlines physical components like the base/lid assembly with dehydrated substrates, plastic prongs, and wells. It also describes a physical process of preparing a suspension and inoculating the base. While there is a software component (the Electronic Codebook), it is used in conjunction with the physical test results.
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 Neisseria and Haemophilus as well as several other fastidious bacteria from clinical specimens." This clearly indicates it's used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Indications for Use: The indications for use specify its use when these organisms "have been isolated in pure culture from clinical specimens in a clinical laboratory." This further reinforces its use with human-derived samples in a clinical setting.
- Device Description: The description details how the system uses biochemical, chromogenic, and fluorogenic substrates to test a suspension prepared from a pure culture isolated from clinical specimens. The results are then interpreted to identify the microorganisms.
- Performance Studies: The performance studies describe evaluating the system's performance using "Fresh, routine isolates as well as previously identified isolates arriving in the clinical laboratory," which are derived from clinical specimens.
- Predicate Device: The mention of a predicate device (K881501; Innovative Diagnostic Systems, Inc., RapID™ NH System) which is also an IVD, further supports the classification of this device as an IVD.
All these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
INTENDED USE: The BBLCRYSTAL™ Neisseria/Haemophilus (N/H) Identification (ID) System is a miniaturized identification method employing modified conventional, fluorogenic, and chromogenic substrates. It is intended for the identification of frequently isolated Nelsseria and Haemophilus as well as several other fastidious bacteria from clinical specimens.
INDICATIONS FOR USE: Use of this product is indicated when Neisseria, Haemophilus and the other fastidious organisms described in Table B-1 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™ N/H ID System is the The Than Componont of the embly, consisting of the CRYSTAL base and lid. The BBLCRYSTAL lid consists of 29 dehydrated biochemical/chromogenic/ The BBCon For AL lies and one fluorogenic negative control, on the ends of noorogenic substrator and the mselving of 30 matching wells; its design plastic promger "The all 30 wells in a single step by pouring the suspension anows inobulation of a target area and tilting the base. The test inoculum of purches the dried substrates and initiates test reactions.
The pure culture suspension is prepared by picking several small colonies of The pare contare coopen media such as Chocolate Agar, Trypticase® Soy the same morphone , Columbia Agar with 5% Sheep Blood, and Agar With o % oncernatively, selective media such as Martin Lewis Agar, Thayer-Martin Modified Agar, New York City Medium Modified, V Agar, and TheyerMarch Moumled Agains of this culture is prepared in the BBLCRYSTAL™ ANR, GP, RGP, N/H ID Inoculum Fluid provided. The Buspension 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 Antor the baced on the BBLCRYSTAL Panel Viewer and the color reactions are visually compared to the BBLCRYSTAL N/H Color Chart provided. Each reaction is scored as a positive (+) or negative (-) and recorded on the BBLCRYSTAL N/H Report Form.
After all results are read, a 10-digit numerical profile is calculated by Arter ung a value of 4, 2, or 1 to each positive reaction. (Negative reactions acelginns = "0".) 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 definitive ID; (8)
- a tie between two or more species; or (b)
- 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 three clinical laboratories, the performance of the In a study conducted at throo billiour leserved was evaluated against
BBLCRYSTAL Neisseria/Heemophilus (N/H) ID System was evely reutine BBCCRYSTAL Nelssena/Asemantional methodologies. Fresh, routine the RapiD " NY System and ochaon as well as previously identified isolates arriving in the clinical laborator you a new utilized in the study. A total of 513 isolates were tested; 93.6% (480) of these isolates were correctly identified (including supplemental testing) using the BBLCRYSTAL" N/H ID identified (including supplemental (octing) and 1.4% (7) yielded a "No ldentification" result.
Reproducibility:
At the same three clinical laboratories, reproducibility of the BBLCRYSTAL" At the same inree clinical laboratories: 10pren (10) Quality Control strains in N/H ID System was established by to vira performed of individual and overall
triplicate on three days. Evaluations were performed of individual and of inter triplicate on three days. Evaluations were ps. of nism reactions, and of interand intra-laboratory reproducibility.
Overall reproducibility was calculated as 95.9%. Reproducibility of individual Overall reproductions ranged from 85.7 to 100%; individual QC organism substrate reactions fanged from 87.7% to 99.2%; and site reproducibility ranged from 95.2% to 97.2%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Clinical Correlation: 93.6% (480) of 513 isolates were correctly identified. 1.4% (7) yielded a "No Identification" result.
Reproducibility: Overall reproducibility was calculated as 95.9%. Reproducibility of individual QC organism substrate reactions ranged from 85.7% to 100%; individual QC organism substrate reactions ranged from 87.7% to 99.2%; and site reproducibility ranged from 95.2% to 97.2%.
Predicate Device(s)
Innovative Diagnostic Systems, Inc., RapID™ NH System (K881501)
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
K962423
Aug. 2, 1996
June 21, 1996
1
SUMMARY OF SAFETY AND EFFECTIVENESS
SUBMITTED BY:
Virginia C. Weinknecht Becton Dickinson Microbiology Systems P O Box 243 Cockeysville, MD 21030-0243
NAME OF DEVICE:
| Trade Name: | BBLCRYSTAL™ Neisseria/Haemophilus (N/H ID System |
|---|---|
| Common Name/Description: | Miniaturized Microorganism ID System |
| Classification Name: | Microbiology - Discs, Strips, and Reagents, Microorganism Differentiation |
PREDICATE DEVICES:
Innovative Diagnostic Systems, Inc., RapID™ NH System (K881501)
DEVICE DESCRIPTION:
INTENDED USE: The BBLCRYSTAL™ Neisseria/Haemophilus (N/H) Identification (ID) System is a miniaturized identification method employing modified conventional, fluorogenic, and chromogenic substrates. It is intended for the identification of frequently isolated Nelsseria and Haemophilus as well as several other fastidious bacteria from clinical specimens.
INDICATIONS FOR USE: Use of this product is indicated when Neisseria, Haemophilus and the other fastidious organisms described in Table B-1 have been isolated in pure culture from clinical specimens in a clinical laboratory, and identification of the microorganisms is desired.
.......
1
Taxa List for BBLCRYSTAL™ Neisseria/Haemophilus (N/H) TABLE B-1: ldentification System
| Actinobacillus
| actinomycetemcomitans | Haemophilus segnis¹ | Neisseria gonorrhoeae |
|---|---|---|
| Kingella denitrificans | Neisseria lactamica | |
| Cardiobacterium hominis¹ | Kingella kingae | Neisseria meningitidis |
| Elkenella corrodens | Kingella species (includes | |
| K. denitrificans and K. kingae) | Neisseria mucosa | |
| Gardnerella vaginalis | Neisseria sicca | |
| Haemophilus | ||
| aphrophilus/paraphrophilus | Moraxella atlantae | Neisseria subflava (includes |
| Moraxella (Branhamella) catarrhalis | N. subflava biovar flava, | |
| N. subflava biovar perflava and | ||
| N. subflava biovar subflava) | ||
| Haemophilus ducreyi | Moraxella lacunata¹ | Neisseria weaverii¹ |
| Haemophilus haemoglobinophilus¹ | Moraxella nonliquefaciens | |
| Haemophilus haemolyticus | Moraxella osloensis | Oligella species (includes |
| O. urethralis and | ||
| O. ureolytica) | ||
| Haemophilus influenzae (includes | ||
| H. influenzae biogroup aegyptius, | Moraxella phenylpyruvica¹ | |
| H. influenzae biotype I, | ||
| H. influenzae biotype II, | Moraxella species (includes | Oligella ureolytica¹ |
| H. influenzae biotype III, | ||
| H. influenzae biotype IV, | M. atlantae, | |
| M. lacunata, | Oligella urethralis | |
| H. influenzae biotype V, | ||
| H. influenzae biotype VI and | M. nonliquefaciens, | |
| M. osloensis and | Pasteurella multocida | |
| H. influenzae biotype VIII ) | M. phenylpyruvica) | Suttonella indologenes |
| Haemophilus parahaemolyticus¹ | Neisseria cinerea¹ | |
| Haemophilus parainfluenzae | ||
| (includes | Neisseria elongata (includes | |
| H. parainfluenzae biotype I, | ||
| H. parainfluenzae biotype II, | N. elongata ssp. elongata, | |
| N. elongata ssp. glycolytica and | ||
| H. parainfluenzae biotype III, | ||
| and H. parainfluenzae biotype IV) | N. elongata ssp. nitroreducens) | |
| Neisseria flavescens¹ |
¹ These taxa have fewer than 10 unique BBLCRYSTAL profiles in the current database.
2
PRODUCT DESCRIPTION:
The main component of the BBLCRYSTAL™ N/H ID System is the The Than Componont of the embly, consisting of the CRYSTAL base and lid. The BBLCRYSTAL lid consists of 29 dehydrated biochemical/chromogenic/ The BBCon For AL lies and one fluorogenic negative control, on the ends of noorogenic substrator and the mselving of 30 matching wells; its design plastic promger "The all 30 wells in a single step by pouring the suspension anows inobulation of a target area and tilting the base. The test inoculum of purches the dried substrates and initiates test reactions.
The pure culture suspension is prepared by picking several small colonies of The pare contare coopen media such as Chocolate Agar, Trypticase® Soy the same morphone , Columbia Agar with 5% Sheep Blood, and Agar With o % oncernatively, selective media such as Martin Lewis Agar, Thayer-Martin Modified Agar, New York City Medium Modified, V Agar, and TheyerMarch Moumled Agains of this culture is prepared in the BBLCRYSTAL™ ANR, GP, RGP, N/H ID Inoculum Fluid provided. The Buspension 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 Antor the baced on the BBLCRYSTAL Panel Viewer and the color reactions are visually compared to the BBLCRYSTAL N/H Color Chart provided. Each reaction is scored as a positive (+) or negative (-) and recorded on the BBLCRYSTAL N/H Report Form.
After all results are read, a 10-digit numerical profile is calculated by Arter ung a value of 4, 2, or 1 to each positive reaction. (Negative reactions acelginns = "0".) 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 definitive ID; (8)
- a tie between two or more species; or (b)
- 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.
B-3
3
In the case where no ID is possible, the Codebook suggests that the user in the case where his is possible. If culture purity has been perform a purity check of the tost isolate is producing atyploal BBLCRYSTAL reactions (which may also be caused by procedurers is unschlo the test species is not part of the intended taxa, or (iii) the system is unable the test species is not part of the required level of confidence. Once user to identify the test labiate with the roquired level that additional testing must be done to establish an identification.
PERFORMANCE DATA:
Clinical Correlation:
In a study conducted at three clinical laboratories, the performance of the In a study conducted at throo billiour leserved was evaluated against
BBLCRYSTAL Neisseria/Heemophilus (N/H) ID System was evely reutine BBCCRYSTAL Nelssena/Asemantional methodologies. Fresh, routine the RapiD " NY System and ochaon as well as previously identified isolates arriving in the clinical laborator you a new utilized in the study. A total of 513 isolates were tested; 93.6% (480) of these isolates were correctly identified (including supplemental testing) using the BBLCRYSTAL" N/H ID identified (including supplemental (octing) and 1.4% (7) yielded a "No ldentification" result.
Reproducibility:
At the same three clinical laboratories, reproducibility of the BBLCRYSTAL" At the same inree clinical laboratories: 10pren (10) Quality Control strains in N/H ID System was established by to vira performed of individual and overall
triplicate on three days. Evaluations were performed of individual and of inter triplicate on three days. Evaluations were ps. of nism reactions, and of interand intra-laboratory reproducibility.
Overall reproducibility was calculated as 95.9%. Reproducibility of individual Overall reproductions ranged from 85.7 to 100%; individual QC organism substrate reactions fanged from 87.7% to 99.2%; and site reproducibility ranged from 95.2% to 97.2%.
167