tested — not confirmed— Real instrument/substrate; the diagnostic or therapeutic interpretation failed testing; a correct reinterpretation remains open (§0.1-B).
The textbook 'instrument is not interpretation' case: real electrodermal measurement, a diagnostic interpretation that fails under blinding. The hardware and the data survive; the organ-diagnosis claim does not.
Origin & lineage
Reinhold Voll, Germany, 1950s.
Claimed mechanism
Skin impedance measured at acupuncture points is read as a diagnosis of organ disease and matched to remedies.
Plausibility
Implausible as a diagnosis — under blinding, readings are no better than chance; the underlying measurement itself is real.
Evidence — grade F
Tested and not confirmed as a diagnostic: blinded operators perform no better than chance.
Market
Makers: Various alt-practitioner device makers (legacy / used market). Models: EAV / Dermatron-type point meters. Price: Used devices ~$200–3,000.
Kernel — keep vs set aside
Keep — real substrate
The voltmeter / ammeter and the skin-impedance (electrodermal) measurement are real instrumentation producing real data. Whether a valid, modern interpretation of electrodermal data exists remains OPEN.
Set aside — claim
The interpretation — that point-impedance readings diagnose specific organ disease or match remedies — failed blinded testing and is rejected.
Regulatory status by jurisdiction
Registration or clearance is a market-access fact, never proof of efficacy.
US — FDA
No accepted standing as a validated diagnostic; not cleared for organ/allergy diagnosis.
EU — MDR
No diagnostic clearance (sold in the alt-practitioner market).