MALDI BIOTYPER CA (MBT-CA) SYSTEM

K130831

BRUKER DALTONICS, INC · cleared 2013-11-21 · product code PEX · Microbiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.4)
“The Bruker Daltonics, Inc MALDI Biotyper CA System is a qualitative in vitro diagnostic mass spectrometer system for the identification of Gram-negative bacterial colonies cultured from human specimens using matrix-assisted laser desorption/ ionization - time of flight (MALDI-TOF) mass spectrometry technology. Data acquisition is controlled with MBT-CA Software. The spectrum of the unknown organism is first transformed into a peak list. Using a biostatistical algorithm, this peak list is compared to the reference peak lists of organisms in the reference library (database) and a log(score) is generated.”
AlgorithmThe MBT-CA System uses a biostatistical algorithm to compare a test organism's spectrum (pattern of mass peaks) with a reference spectra library (database) to generate a log(score) for organism identification.
source quote (p.4)
“The MBT-CA System uses a different methodology for organism identification based on unique protein patterns of the microorganisms obtained from mass spectrometry. The test organism's spectrum (a pattern of mass peaks) is compared with a reference spectra library (database). Using biostatistical analysis, a probability ranking of the organism identification is generated. Data acquisition is controlled with MBT-CA Software. The spectrum of the unknown organism is first transformed into a peak list. Using a biostatistical algorithm, this peak list is compared to the reference peak lists of organisms in the reference library (database) and a log(score) is generated.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (15)

Bench

n=720 other

endpoints: repeatability and precision of the MALDI Biotyper CA System

Bench

n=7 other

endpoints: establish the estimated dynamic range of sample size for both the Direct Transfer (DT) and Extraction method (Ext) procedure

Bench

n=26 other

endpoints: validate the performance of the proposed MALDI Biotyper CA System reference library by ensuring that organisms not included in the reference library would not yield an incorrect identification; demonstrate that the MALDI Biotyper CA System identification is not impacted when closely related species not included in the reference library are run on the system

Bench

n=128 other

endpoints: assess the effect of testing a mixed culture on MALDI Biotyper CA identification

Bench

n=7 patients

endpoints: confirm the acceptability of the recommended agar/media and stability of the colony for up to 12 hours prior to analysis

Bench

n=4 other

endpoints: demonstrate that impurities such as salts, peptides or carbohydrates introduced from culture media do not interfere with MALDI Biotyper CA identification

Bench

n=3 patients

endpoints: assess isolate stability on the target plate prior to matrix overlay; confirm the stability of extracted material prior to target plate inoculation

Bench

n=3 patients

endpoints: prove the stability of test organisms on the spotted target plate following matrix addition at various temperature and relative humidity conditions

Bench

n=3 other

endpoints: determine the stability of unreconstituted and reconstituted BTS material

Bench

n=3 other

endpoints: determine the stability of unreconstituted matrix as well as in-use (reconstituted) matrix

Bench

n=2 other

endpoints: determine the effect of cross-contamination; determine the effect of carry-over

Bench

n=4 sites · 4 site(s)

endpoints: ensure that each operator was familiar with all aspects of instrument operation

Retrospective clinical

n=800 other · 4 site(s)

endpoints: confirm day-to-day reproducibility and precision of the MALDI Biotyper CA System on different clinical study sites

Retrospective clinical

n=100 patients · 5 site(s)

endpoints: confirm intra laboratory performance of the MALDI Biotyper CA System

Retrospective clinical

n=2,263 cases · 4 site(s)

endpoints: demonstrate performance of the MALDI Biotyper CA (MBT-CA) System

standards: MM-18 A guidelines

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Microbiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K130831