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K Number
K022455
Device Name
SPIFE LD-12 KIT, MODEL 3338
Manufacturer
HELENA LABORATORIES
Date Cleared
2002-10-01

(67 days)

Product Code
CFE
Regulation Number
862.1445
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The SPIFE LD test system can be used in conjunction with CK isoenzyme studies to aid in the diagnosis of myocardial infarction. The LD1/LD2 "flip" can be present in patients after acute MI, severe anemias, renal necrosis and in-vivo or in-vitro hemolysis of any cause.

The LD5 is increased in skeletal muscle injury or diseases, cirrhosis, hepatitis and passive liver congestion.

Mid-zone fractions (LD2,3,4) are increased in cases of massive platelet destruction (pulmonary embolism) and in lymphatic system involvements such as mononucleosis, lymphomas and lymphocytic leukemias.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information about the acceptance criteria or the study that proves the device meets specific performance criteria. The document is a 510(k) clearance letter from the FDA for a device called "SPIFE LD-12 Isoenzyme Kit."

This letter primarily focuses on:

  • Substantial Equivalence: Stating that the device is substantially equivalent to a legally marketed predicate device.
  • Regulatory Classification: Identifying the regulation number, name, and regulatory class (Class II).
  • General Controls: Informing the manufacturer about applicable general controls provisions of the Federal Food, Drug, and Cosmetic Act.
  • Marketing Authorization: Granting permission to market the device.
  • Indications for Use: Briefly describing the intended use of the device in relation to diagnostic conditions such as myocardial infarction, skeletal muscle injury, and lymphatic system involvements.

The document does not contain data tables, sample sizes for test or training sets, details on ground truth establishment, expert qualifications, adjudication methods, or results from any performance studies (standalone or MRMC).

§ 862.1445 Lactate dehydrogenase isoenzymes test system.

(a)
Identification. A lactate dehydrogenase isoenzymes test system is a device intended to measure the activity of lactate dehydrogenase isoenzymes (a group of enzymes with similar biological activity) in serum. Measurements of lactate dehydrogenase isoenzymes are used in the diagnosis and treatment of liver diseases, such as viral hepatitis, and myocardial infarction.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.