BBLCRYSTAL NEISSERIA/HAEMOPHILUS (N/H) SYSTEM

K962423 · Becton Dickinson Microbiology Systems · JST · Aug 2, 1996 · Microbiology

Device Facts

• Record ID: K962423
• Device Name: BBLCRYSTAL NEISSERIA/HAEMOPHILUS (N/H) SYSTEM
• Applicant: Becton Dickinson Microbiology Systems
• Product Code: JST · Microbiology
• Decision Date: Aug 2, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2660
• Device Class: Class 1
• Attributes: Software as a Medical Device

Indications for 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 Neisseria and Haemophilus as well as several other fastidious bacteria from clinical specimens.

Device Story

Microorganism identification system for fastidious bacteria; utilizes panel with 29 dehydrated biochemical/chromogenic/fluorogenic substrates and one negative control. User prepares pure culture suspension from clinical specimen; inoculates panel base; incubates 4 hours at 35-37°C. Visual color reactions scored as positive/negative; 10-digit numerical profile calculated by summing assigned values (4, 2, 1) for positive reactions. Profile entered into PC-based Electronic Codebook software to generate identification result (definitive, tie, or no ID). Assists clinical microbiologists in identifying pathogens; facilitates appropriate clinical decision-making.

Clinical Evidence

Clinical study at three laboratories evaluated 513 isolates against RapID™ NH and conventional methods. 93.6% (480/513) correct identification, 5.1% incorrect, 1.4% no ID. Reproducibility study (10 QC strains, triplicate, 3 days) showed 95.9% overall reproducibility; individual substrate reproducibility 85.7-100%.

Technological Characteristics

Miniaturized panel with 30 wells; dehydrated biochemical, chromogenic, and fluorogenic substrates. Manual inoculation; visual colorimetric/fluorometric readout. PC-based software for profile calculation and database matching. No specialized energy source required for reaction; incubation at 35-37°C.

Indications for Use

Indicated for identification of Neisseria, Haemophilus, and other fastidious bacteria (e.g., Actinobacillus, Cardiobacterium, Eikenella, Gardnerella, Kingella, Moraxella, Oligella, Pasteurella, Suttonella) isolated in pure culture from clinical specimens in a clinical laboratory.

Regulatory Classification

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.

Predicate Devices

• Innovative Diagnostic Systems, Inc., RapID™ NH System (K881501)

Submission Summary (Full Text)

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K962423
Aug. 2, 1996
June 21, 1996

# 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 Neisseria 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.

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TABLE B-1: Taxa List for BBLCRYSTAL™ Neisseria/Haemophilus (N/H) Identification System

| Actinobacillus
actinomycetemcomitans | Haemophilus segnis¹ | Neisseria gonorrhoeae |
| --- | --- | --- |
| | Kingella denitrificans | Neisseria lactamica |
| Cardiobacterium hominis¹ | Kingella kingae | Neisseria meningitidis |
| Eikenella corrodens | Kingella species (includes
K. denitrificans and K. kingae) | Neisseria mucosa |
| Gardnerella vaginalis | | Neisseria sicca |
| Haemophilus
aphrophilus/paraphrophilus | Moraxella atlantae | Neisseria subflava (includes
N. subflava biovar flava,
N. subflava biovar perflava and
N. subflava biovar subflava) |
| Haemophilus ducreyi | Moraxella lacunata¹ | |
| Haemophilus haemoglobinophilus¹ | Moraxella nonliquefaciens | Neisseria weaverii¹ |
| Haemophilus haemolyticus | Moraxella osloensis | Oligella species (includes
O. urethralis and
O. ureolytica) |
| Haemophilus influenzae (includes
H. influenzae biogroup aegyptius,
H. influenzae biotype I,
H. influenzae biotype II,
H. influenzae biotype III,
H. influenzae biotype IV,
H. influenzae biotype V,
H. influenzae biotype VI and
H. influenzae biotype VIII) | Moraxella phenylpyruvica¹ | Oligella ureolytica¹ |
| | Moraxella species (includes
M. atlantae,
M. lacunata,
M. nonliquefaciens,
M. osloensis and
M. phenylpyruvica) | Oligella ureolytica¹ |
| | | Pasteurella multocida |
| | | Suttonella indologenes |
| Haemophilus parahaemolyticus¹ | Neisseria cinerea¹ | |
| Haemophilus parainfluenzae
(includes
H. parainfluenzae biotype I,
H. parainfluenzae biotype II,
H. parainfluenzae biotype III,
and H. parainfluenzae biotype IV) | Neisseria elongata (includes
N. elongata ssp. elongata,
N. elongata ssp. glycolytica and
N. elongata ssp. nitroreducens) | |
| | Neisseria flavescens¹ | |

¹ These taxa have fewer than 10 unique BBLCRYSTAL profiles in the current database.

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# PRODUCT DESCRIPTION:

The main component of the BBLCRYSTAL™ N/H ID System is the BBLCRYSTAL N/H 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 Chocolate Agar, Trypticase® Soy Agar with 5% Sheep Blood, Columbia Agar with 5% Sheep Blood, and Nutrient Agar, or alternatively, selective media such as Martin Lewis Agar, Thayer-Martin Modified Agar, New York City Medium Modified, V Agar, and GC-Lect® Agar. 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 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 assigning a value of 4, 2, or 1 to each positive reaction. (Negative reactions are scored as "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) a definitive ID;
(b) a tie between two or more species; or
(c) no ID possible with data submitted.

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.

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In the case where no ID is possible, the Codebook suggests that the user perform a purity check of the test isolate. If culture purity has been confirmed, then it is likely that (i) the test isolate is producing atypical BBLCRYSTAL reactions (which may also be caused by procedural errors), (ii) the test species is not part of the intended taxa, or (iii) the system is unable to identify the test isolate with the required level of confidence. Once user error has been ruled out, the Codebook suggests 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 BBLCRYSTAL Neisseria/Haemophilus (N/H) ID System was evaluated against the RapID™ NH System 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 513 isolates were tested; 93.6% (480) of these isolates were correctly identified (including supplemental testing) using the BBLCRYSTAL™ N/H ID System; 5.1% (26) were incorrectly identified; and 1.4% (7) yielded a "No Identification" result.

### Reproducibility:

At the same three clinical laboratories, reproducibility of the BBLCRYSTAL™ N/H 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 inter- and intra-laboratory reproducibility.

Overall reproducibility was calculated as 95.9%. Reproducibility of individual substrate reactions ranged from 85.7 to 100%; individual QC organism reaction reproducibility ranged from 87.7% to 99.2%; and site reproducibility ranged from 95.2% to 97.2%.

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