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K Number
K971467
Device Name
SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU)
Manufacturer
CAROLINA LIQUID CHEMISTRIES CORP.
Date Cleared
1997-06-16

(55 days)

Product Code
CFR
Regulation Number
862.1345
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Glucose Reagent is intended for the quantitative determination of serum glucose using the Beckman SYNCHRON CX Clinical Systems. The results are used in the diagnosis and treatment of diabetes mellitus, neonatal and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Device Description

Not Found

AI/ML Overview

This letter is a 510(k) clearance for the SYNCHRON CX Systems Glucose Reagent (GLU) and does not contain the detailed study information required to fully answer the request. The document states that the device is "substantially equivalent" to predicate devices, but it does not provide acceptance criteria, performance data, or details about the studies conducted. Therefore, I cannot extract the information requested in points 1 through 9.

Here's why some of the specific points cannot be addressed:

  • 1. A table of acceptance criteria and the reported device performance: This information is not present. The letter only grants clearance based on substantial equivalence.
  • 2. Sample sized used for the test set and the data provenance: Not available in this document.
  • 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
  • 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available.
  • 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is a glucose reagent, not an AI-assisted diagnostic imaging device for human readers. This question is not applicable.
  • 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: As this is a reagent, it functions in conjunction with a laboratory instrument, not as a standalone algorithm in the sense of AI.
  • 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not available.
  • 8. The sample size for the training set: Not available. This is a reagent, not typically "trained" in the AI sense.
  • 9. How the ground truth for the training set was established: Not available.

To get the requested information, one would need to refer to the original 510(k) submission document (K971467) itself, which would contain the scientific and clinical data supporting the substantial equivalence claim.

§ 862.1345 Glucose test system.

(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.